Surgical Technique Guide
Surgical Technique Guide
The following general Surgical Technique Guide is for illustrative purposes only. As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as to the best treatment for each patient. Detailed preoperative clinical and diagnostic evaluation followed by carefully executed surgical technique is essential. Only those individuals with specialized training and experience in spinal surgery should attempt to use the Silverton Spinal Fixation and Silverton-D Deformity Systems. Refer to the Instructions for Use for a more complete description of indications, contraindications, warnings, cautions and other information about the system.
The Silverton® Spinal Fixation System combined with the Silverton-D® Deformity System supports the surgical correction of various spinal deformities, including scoliosis, in addition to the treatment of various conditions such as degenerative disc disease, spinal stenosis and trauma.
2 BIOMET SPINE
The Silverton® Spinal Fixation System combined with the Silverton-D® Deformity System supports the surgical correction of various spinal deformities, including scoliosis, in addition to the treatment of various conditions such as degenerative disc disease, spinal stenosis and trauma. The selection of pedicle screws, rods, connectors and hooks provides temporary vertebral stabilization of spinal segments in the thoracic, lumbar and sacral regions during spinal fusion.
The systems are surgeon-guided to incorporate unique and critical features while providing versatility, excellent construct strength and intuitive instrumentation.
FEATURES: •Lowprofile:providesminimaltissueirritation
•Toploading/toptightening:conservestissue,whilesimplifyingconstructassembly
•Anti-splayreversebuttressthread:convertstorqueintogrippingforcewithoutheadsplay
•Screwthreaddesign:constantouterdiameterwithtaperedminordiameterprovidesmaximumpurchaseofcorticalandcancellousbone
•Lockingmechanism:designedtomaximizeforceperunitareaforunparalleledlockingstrength
•Simple,intuitiveinstrumentation:instrumentsarewellthoughtoutandthetraysarearrangedinsequenceofuse
•Crossconnectorjaws:contouredtominimizenotchingoftherod
•Multiplerodtypes:straightandpre-bentrodswiththreedifferentmaterialoptions
•Specializedimplants:allowforintaroperativeversatility
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 3
Figure1 Patient positioning
PREOPERATIVE PREPARATION•Reviewandinspectallinstrumentationandimplants
priortosterilization.
•Implantsandinstrumentsareprovidednon-sterileandmustbecleanedandsterilizedpriortouse.
•Replaceoraddanyneededcomponentsfortheplannedsurgery.
•Primarysurgeonmustbefullyexperiencedwiththerequiredposterior,occipito-cervico-thoracicinstrumentationtechniques.
SURGICAL EXPOSURE AND SITE PREPARATION•Patientpositioningiscriticalforoccipito-cervical
fusionprocedures.
•Thepatientshouldbeplacedontheoperatingtableinthepronepositionwiththepatient’sheadsecurelyimmobilized.
•Beforedraping,confirmproperpatientpositionbydirectvisualizationandbyradiograph.
•Alwaysusecautionwhenpositioningthepatient,asphysiologicalalignmentmaynotbeattainable.
•Performastandardmidlinesubperiostealexposureoftheportionofthecervico-thoracicspinetobefused.
•Completeawideexposureextendingtothelateralaspectofthefacetjointsinthecervicalspineandthetransverseprocessesinthethoracicspine.
•Extendtheexposuretotheexternaloccipitalprotuberanceifthefusionwillincludetheocciput.
•Bemindfulofavoidinginjurytothevertebralarteries,spinalcordandC2nerverootsintheuppercervicalspine.Caremustalsobetakentoavoidthefacetcapsulesandinterspinousligamentsatlevelsthatwillnotbefused.
4 BIOMET SPINE
1. •Theawl isusedtopenetratetheoutercortexofthepedicleand
cannotbeinsertedbeyond10mm(Figure 1).
2. •Eitherthestraight pedicle probe orthecurved pedicle probe
canbeusedtolocalizethepedicleandopenapathway.Correctrotationalinsertionoftheinstrumentwillallowtheprobetofollowapathofleastresistancewithoutviolatingthepediclewalls.Thepedicleprobesarelasermarkedat10mmintervalstodisplaydepthandaidinappropriatescrewlengthselection(Figure 2).
3. •Thestraight sounder andcurved sounder areball-tippedfeeler
probesdesignedtoassistthesurgeoninassessingtheintegrityofthepediclewallsandanteriorcortexafteruseofthepedicleprobes.Thesoundersalsoincludedepthmarkingsat10mmintervals(Figure 3).
4. •Tapsmaybeused,althoughtheSilverton®pediclescrews
areself-tapping.Tapsaresizedexactlyasthecorrespondingpediclescrew,thereforeundertappingmaybedesired.Tapsareavailableinfourdiameters(4.5mm, 5.5mm,6.5mmand7.5mm)andmaybeattachedtoeithertheratcheting straight handleorT-handle.Thetapsarelasermarkedinthesamemannerastheprobesandsounders.Tapthreadlengthis30mm(Figure 4).
PEDICLE SCREW PREPARATION
Figure1
Figure2
Figure3
Figure 4
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 5
5. •Thepediclescrewsareinsertedwiththebone screw driver
whichisattachedtoeithertheratchetingstraighthandleorT-handle.Thestrawisaslipsleevethataidsinpreventinginadvertentdisengagementofthescrewduringinsertion.
•Thebonescrewdriverconsistsof3 elements:
a.bone screw driver shaft
b.bone screw driver sleeve
c.bone screw driver straw
6. •Whenloadingascrewontothebonescrewdriver:
a.Drawthesleevewiththestrawupwardtowardthehandle.
b.Orienttheprongswiththescrewheadslotsandinsert.
c.Withtheprongsproperlyseated,thesleeveassemblyis threadedintothescrewheadbyrotatingclockwise.
Note: The prongs of the screw driver tip need to align and engage into the corresponding screw head slots. It is helpful to gently rotate the screw shaft until the prongs are seated into the grooves on the head of the screw shaft. If the screw driver prongs are not seated, the screw cannot be loaded.
7. •Theratchetinghandleshouldbesetforproperrotationdirection
(clockwiseorneutralforinsertion).Thisisaccomplishedbyrotatingthemetalcollaronthehandle.
BONE SCREW DRIVER SHAFT
BONE SCREW DRIVER SLEEVE
BONE SCREW DRIVER STRAW
SCREW LOADING
PEDICLE SCREW INSERTION
6 BIOMET SPINE
8. •Oncethedesiredinsertiondepthisachieved,thescrew
canbedisengagedfromthescrewdriver(Figure 5).
a.Graspandmaintainthepositionoftheratchethandle/ screwdrivershaftassembly.
b.Unthreadthesleevefromthescrewheadandremove.
c.Confirmappropriateimplantlocationradiographically.
Note: For subsequent screw removal or height adjustment, the screw loading sequence must be used. Do not attempt to turn the screw without having the sleeve threaded into the screw head, as this may cause the driver tips to be damaged.
9. •Thepolyaxialscrewheadmaybepositionedandalignedusing
thebone screw driver/head turner (Figure 6).
SCREW HEAD ADJUSTMENT
Figure 5
Figure 6
PEDICLE SCREW INSERTION (CONTINUED)
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 7
10. •TheSilvertonSpinalFixationSystemincludespre-bentrodsin
10mmincrementsanda400mmstraightrod.IntheSilverton-DDeformitySystem,rigid(Ti-6Al-4V),cobaltchrome(CoCrMo),andmalleablerods(CpTi)areincludedwithahexagonalendforrodrotationifrequired.Forrodbending/contouring,a french rod bender orin situ rod bendersmaybeutilized.
11. •Usingtherod inserter,placetheselectedrodintothescrew
heads.Foradditionalrodinsertionorasanalternative,therod holder maybeused.Provisionalsetscrewtighteningmaybeneededtostabilizetherod(Figure 8).
12. •Additionalrodmanipulationmaybeneededforsetscrew
placement;therod pusher orset screw guide maybeusedtoestablishthedirectaxialpathwaytothescrewheadforsetscrewplacement.Thesetscrewguidehasaslightlylargerdistalendthatisplacedoverthescrewheadandrod.Withdownwardpressure,pushtherodintotheproperpositionofthescrewheadandintroducethesetscrewdownthecannulatedshaft(Figure 9).
ROD CONTOURING
ROD PLACEMENT
Once all the screws are placed, an approximately sized rod may be chosen. 500mm rod templates are available in both the Silverton® and Silverton-D® Deformity spinal fixation system surgical cases (Figure 7).
Figure 7
Figure 8
Figure 9
8 BIOMET SPINE
13. •Therod rockermaybeusedtointroducetherodintothescrew
headwiththeuseofaleveringaction(Figure 10).
14. •Therod persuader generatessignificantforcetoapproximate
thescrewheadandrod.Ensurethattheratchetmechanismisfullydisengagedandplacethearmsintothegroovesonbothsidesofthescrewhead.Re-engagetheratchetandgraduallysqueezethepistolgripuntilratchetingstops.Introducethesetscrewdownthecannulatedshaftandprovisionallytighten.Todisengagetheinstrumentfromthescrew,releasetheratchetlockandrotatetheinstrument90degrees(Figure 11).
•Oncetherodisfullyseated,theremainingsetscrewsmaybeplacedtosecuretherod.
SET SCREW PLACEMENT
Figure 10
Figure 11
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 9
15. •Theset screw starter isaself-retainingdouble-ended
instrumentdesignedforinitialthreadingandprovisionaltighteningofthesetscrews.Caremustbetakentoavoidhightorques,asthismaydamagetheinstrumenttip.
Note: The reverse buttress thread design of the set screw requires the set screw to be oriented correctly prior to insertion. If it is loaded onto the set screw starter upside down, it will not engage the screw head. Insert the starter or driver into the set screw such that the gold side of the set screw is facing up.
Tip: It is helpful to begin the set screw engagement by rotating the set screw counterclockwise. No more than a one-half turn should be required. During the counterclockwise rotation, a tactile click will indicate that the lead thread is in ideal position to engage. Once the click is felt, the clockwise tightening direction should be started (Figure 12).
•AdditionalCorrectiveManeuvers:WheninsertingtheSilverton-D®malleable,rigidorcobaltchromerods,manipulationoftherodandpediclescrewheadangulationscanbeachievedwhenusingthederotation wrench ontherodhexagonalendandusingthederotation tube onthepediclescrewhead.
Figure 12
10 BIOMET SPINE
16. •Oncetherodhasbeenfullyseatedintoallofthepolyaxial
screwheadsandthesetscrewsareinplace,distractionorcompressionmaybeaccomplishedusingeitherthedistractor orthecompressor(Figure 13a,b).
17.FINAL TIGHTENING •Finaltighteningisperformedusingthefollowingthree
instruments:counter torque,torque limiting handle andthe set screw tightener.
•Attachthe(a)torquelimitinghandletothe(b)setscrewtightenerandinsertintothe(c)countertorqueinstrument.
18. •Whileretractingthecountertorquetovisualizefullengagement
ofthesetscrew,placethetipofthesetscrewtightenerintothesetscrewforfinaltightening(Figure 14).
19. •Lowerthecountertorqueoverthescrewheadwhileengaging
therod.Thenrotatethetorquelimitinghandleclockwiseuntilasnapisheard.Finaltighteningisaccomplishedat80in-lb(9.0Nm)(Figure 15).
COMPRESSION AND DISTRACTION
(a) TORQUE LIMITING HANDLE
(b) SET SCREW TIGHTENER
(c) COUNTER TORQUE INSTRUMENT
Figure 13a
Figure 13b
Figure 14
Figure 15
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 11
20.CROSS CONNECTORS •Forinitialplacementormanualtighteningofthecross
connectortotherods,usetheset screw driver shaft cross connector.Backoutthesetscrewsenoughtoallowthejawstoadequatelyencompasstherods(Figure 16).
Note: Fixed and variable cross connectors are available. The fixed version comes in specific lengths for use in situations where rods are parallel; the variable cross connectors can accommodate rods from 40–80mm apart (See page 22).
21. •Oncethejawshavecapturedtherods,tightenthesetscrews
(Figure 17).
•Provisionaltighteningofthevariablecrossconnectorcanbeachievedviathecentralnutusingthenut driver shaft cross connector.
22. •Finaltighteningofthecrossconnectorisachievedbyusing
thetorque limiting handle 40 in-lb (4.5Nm)inconjunctionwiththeset screw driver shaft cross connectorforconnectiontotherodsandthenut driver shaft cross connectorforthecentralnutonthevariablecrossconnector.
Note: If needed, the cross connector bender may be used. Prior to bending a variable cross connector, set the length as needed and provisionally tighten the central nut.
Figure 17
Figure 16
12 BIOMET SPINE
MONOAXIAL SCREWS •Monoaxialscrewsarecolorcodeddependingonthescrew
diameter.Variousconfigurationsofscrewdiameterandlengthareavailable,rangingfrom4.5–8.5mmscrewdiameterswithscrewlengthsof25–100mm.Afterthepediclesareprepared(asexplainedearlier),themonoaxialscrewisplacedusingthemono bone screw driver,bone screw driver sleeveandthebone screw driver straw.
COMPRESSION AND DISTRACTION (CONTINUED)
BONE SCREW DRIVER STRAW
BONE SCREW DRIVER SLEEVE
MONO BONE SCREW DRIVER
MONOAXIAL SCREW DRIVER ENGAGEMENT
MONOAXIAL SCREWS
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 13
REDUCTION SCREWS •Ifrequired,theSilverton-D®reductionscrewsareavailablefor
rodreductionorreductionofspondylolisthesis.Silverton-Dreductionscrewsareavailablein5.5mm,6.5mmand7.5mmscrewdiameterswith35mm,40mm,45mmand 50mmscrewlengths.Afterthepediclesareprepared(asexplainedearlier),thereductionscrewsareplacedusingthereduction screw driver shaft,bone screw driver sleeve,andthereduction strawconnectedtotheratcheting straight handleorT-handle.
•Ifneeded,therodreductiontechniqueslistedabovemaybeusedtoapproximatetherodwithinthetuliphead.Toassistinsetscrewalignmentwiththethreadsintheheadofthereductionscrew,theanti-splay ringorthereduction strawcanbeappliedandprovisionaltighteningcompleted(Figure 18a,b).
•Theextendedportionofthereductionscrewcannowberemovedusingthereduction screw pliers.Thisisaccomplishedbyslidingthereductionscrewpliersovereachextendedtabofthescrewheadandleveragingfirstinamedialthenlateraldirectiontoavoidpossiblescrewheadsplay.Themedial,lateralactionmayneedtoberepeatedseveraltimesuntileachtabisbrokenoff.Finalsetscrewtighteningcanbeperformedusingthereduction counter torque inconjunctionwiththesetscrewtightenerandthetorquelimitinghandle,whichissetatatorqueof80in-lb(9.0Nm).
BONE SCREW DRIVER SLEEVE
REDUCTION STRAW
REDUCTION SCREW TAB REMOVAL REDUCTION SCREW DRIVER ENGAGEMENT
REDUCTION BONE SCREW DRIVER SHAFT
Figure 18a
Figure 18b
14 BIOMET SPINE
HOOK INSERTION
23. •LaminarHooks:Thelaminaispreparedwiththelamina hook
finder.Asmallosteotomemaybeneededtopreparethelaminaforthehook,andtheligamentumflavummustbescrapedofftheundersideofthelamina.Thiswillallowatightandsecurefitofthehook.Thelaminarhookfinderisusedtodeterminetheappropriatehooksizeandlocationinpreparationofhookplacement(Figure 19).
Note: Extended body, ramped blade, angled blade, angled and offset hooks are placed using the same technique as with the laminar hooks.
•Attachtheselectedhooktoeitherthestraight orlateral hook holder.Thehookisinsertedinadownwardrotationalmotion,allowingthebladetiptohugtheundersideofthelamina.Thehook pusher maybeusedtohelpguideandseatthehookagainstthelamina.
24. •PedicleHooks:Alwaysdirectedinthecephaladdirection,the
pediclehooksareplacedintothefacetjointwiththebifidtipagainstthepedicle.Thepedicle hook finder isusedtoidentifythepedicleandprepareasiteforthehooktoevenlyseatontothepedicle.Pediclehooksareinsertedusingeitherthestraightorlateralhookholder(Figure 20).
•Finaltighteninginstrumentationisexplainedonpage10.
HOOKS
Thirteen hook configurations are available in various sizes and angulations, depending on the position and placement in the non-cervical spine (see page 23 for hook styles). After appropriate dissection and anatomic levels are verified, the hook sites can be prepared and appropriate hooks selected.
Figure 19
Figure 20
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 15
25. •Aftertheoffsetconnectorhasbeenselectedandpositioned,
setscrewtighteningiscomplete(Figure 21).
a.Openoffsetconnectorsusethestandard set screws. Finaltighteningisperformedusingthefollowing instruments:countertorque,torquelimitinghandle andthesetscrewtightener.
b.Closedoffsetconnectorsusethesmall set screws.Final tighteningisperformedusingthefollowinginstruments: small set screw tightener gold tip andtorquelimitinghandle 40 in-lb(4.5Nm).
Offset connectors allow medial and lateral variability when connecting screws to a rod. This may be useful when attempting to capture the rod between screws and hooks. Closed offset connectors may be pre-loaded on the rod prior to placement into the screw or hook head. The small set screws are used for this connection. The regular set screws are used to tighten the open offset connectors to the rod.
Offset connectors are offered in three open lengths: 15mm, 25mm and 40mm. There is also one closed offset connector with a length of 40mm.
OFFSET CONNECTORS
Figure 21
16 BIOMET SPINE
PARALLEL CONNECTOR, 2X2
PARALLEL CONNECTOR, 1X2
PARALLEL CONNECTOR, EXTENDED BODY 1X2
PARALLEL CONNECTOR, EXTENDED BODY 2X2
AXIAL CONNECTOR
ROD TO ROD CONNECTORS
Parallel and axial connectors are used to either increase the length or approximate two independent rods by joining them together.
There are four different configurations of parallel connectors and one axial connector.
26. •Aftertherod-to-rodconnectorhasbeenselectedandpositioned,
setscrewtighteningiscompletedusingthefollowinginstruments:smallsetscrewtightenergoldtipandtorquelimitinghandle, 40 in-lb(4.5Nm).
Note: For tightening of the special order items (parallel connector open and parallel connector extended body open), the set screws are tightened using the set screw tightener short.
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 17
CLOSURE
REMOVING THE SILVERTON® SPINAL FIXATION SYSTEM (IF NECESSARY)
1.Deteriorationofthedeviceafterboneconsolidationcannotbeconsideredtoconstituteadysfunctionordeteriorationinthecharacteristicsoftheimplant.Theimplantcanberemovedaftertheconsolidationofthebonegraft.
2.Ifanonuniondevelopsorifthecomponentsloosen,bend,and/orbreak,reviseand/orremovethedevice(s)immediatelybeforeseriousinjuryoccurs.Failuretoimmobilizeadelayednonunionofbonewillresultinexcessiveandrepeatedstressesontheimplant.Bythemechanismoffatigue,thesestressescancauseeventualbending,looseningorbreakageofthedevice(s).
3.Theimplantmayberemovedafterhealing.Particularlyinyoungactivepatients,implantsmayloosen,fracture,corrode,migrate,andincreasetheriskofinfection,causepain,orstresstheshieldbone–evenafternormalhealing.Thesurgeonmustconsidertherisksandbenefitswhendecidingwhetherornottoremoveanimplant.Implantremovalmustbefollowedbycarefulpostoperativemanagementtoavoidre-fracture.Ifthepatientisolderandhasalowactivitylevel,thesurgeonmayelectnottoremovetheimplantinordertoeliminatetherisksofanothersurgery.
4.Neverreuseexplantedsurgicalimplants.
5.Standardsetscrewremovalmaybeaccomplishedusingcountertorque,thesetscrewtightenerandtheT-handlefixed.Whenallofthesetscrewshavebeenremoved,therodmayberemovedusingtherodinserterortherodholder.Thetorquelimitinghandleshouldneverbeusedtoremovesetscrews.
6.Polyaxialpediclescrewremovalmaybeaccomplishedusingthebonescrewdriver.Inordertoensureatightfitbetweenthescrewandthescrewdriver,itisrecommendedthatallthreescrewdrivercomponentsareusedwhenremovingpediclescrews(shaft,sleeve,straw).Itmaybenecessarytorotatetheheadoftheimplantedscrewtoallowtheprongsoftheshafttoalignwithandengagetheslotsontheheadofthescrewshaft.
6.Monoaxialscrewsmayberemovedusingthemonoaxialbonescrewdriverinadditiontotheoutersleeveandstraw.
27. •Closewoundanddressintheusualfashion.
18 BIOMET SPINE
SILVERTON® INSTRUMENTS
Bone Awl Trocar Point • 7704-1001
Straight Handle Ratcheting • 7704-1030
T-Handle Ratcheting • 7704-1031
Rod Template • 7704-1067
Bone Screw Driver/Head Turner Monoaxial • 7704-1046
Rod Inserter 5.5mm • 7704-1041
Rod Holder • 7704-1042
Rod Rocker • 7704-1090
Rod Pusher 5.5mm Rod • 7704-1092
Pedicle Bone Probe Straight 3.7mm • 7704-1002
Pedicle Bone Probe Curved 3.7mm • 7704-1003
Sounder Straight • 7704-1004
Sounder Curved • 7704-1006
Tap 4.5mm • 7704-1024
Tap 5.5mm • 7704-1025
Tap 6.5mm • 7704-1026
Tap 7.5mm • 7704-1027
Bone Screw Driver Shaft • 7704-1235
Bone Screw Driver Sleeve • 7704-1035
Bone Screw Driver Straw • 7704-1035-003
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 19
T-Handle Fixed • 9803-0001
Rod Persuader • 7704-1095
Set Screw Starter • 7704-1037
In Situ Rod Benders Left & Right Set • 7704-1060
French Rod Bender • 7704-1065
Distractor • 7704-1070
Compressor 65mm • 7704-1076
Torque Limiting T-Handle • 7704-1181 Non-Cannulated
Counter Torque • 7704-1285
Set Screw Guide Shaft • 7704-1036Set Screw Tightener Short • 7706-1139
Table Top Rotary Rod Cutter • 7704-1066
Cross Connector Bender • 7705-1060
Set Screw Driver Shaft Cross Connector • 7705-1110
Nut Driver Shaft Cross Connector • 7705-1120
Cross Connector Sizing Card • 7704-1201
Torque Limiting Handle 40 in-lb • 7704-1240
20 BIOMET SPINE
SILVERTON-D® INSTRUMENTS
Laminar Hook Finder • 7704-3011
Pedicle Hook Finder Narrow • 7704-3013
Pedicle Hook Finder TP Large • 7704-3014
Straight Hook Holder • 7704-3020
Lateral Hook Holder • 7704-3021
Hook Pusher • 7704-3030
Reduction Counter Torque • 7704-1086
Reduction Bone Screw Driver Shaft • 7704-1935
Reduction Screw Driver Straw • 7704-1936
Monoaxial Bone Screw Driver Shaft • 7704-1147
Set Screw Tightener • 7704-1138
Rod Template, 500mm • 7704-3050
Small Set Screw Tightener, Gold Tip • 7704-3138
Wrench Derotation • 7704-3041
Derotation Tube Deformity • 7704-3036
Reduction Screw Pliers • 7704-3019
Anti-Splay Ring • 7704-1937
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 21
SILVERTON® IMPLANTS
Polyaxial Pedicle Screws
Part # Diameter Length
7715-4525* 4.5mm 25mm
7715-4530* 4.5mm 30mm
7715-4535* 4.5mm 35mm
7715-4540* 4.5mm 40mm
7715-4545* 4.5mm 45mm
7715-5530 5.5mm 30mm
7715-5535 5.5mm 35mm
7715-5540 5.5mm 40mm
7715-5545 5.5mm 45mm
7715-5550 5.5mm 50mm
7715-6530 6.5mm 30mm
7715-6535 6.5mm 35mm
7715-6540 6.5mm 40mm
7715-6545 6.5mm 45mm
7715-6550 6.5mm 50mm
7715-6555 6.5mm 55mm
7715-7530 7.5mm 30mm
7715-7535 7.5mm 35mm
7715-7540 7.5mm 40mm
7715-7545 7.5mm 45mm
7715-7550 7.5mm 50mm
7715-7555 7.5mm 55mm
Titanium Straight Rods, Pre-Cut
Part # Diameter Length
7701-0030 5.5mm 30mm
7701-0035 5.5mm 35mm
7701-0040 5.5mm 40mm
7701-0045 5.5mm 45mm
7701-0050 5.5mm 50mm
7701-0055 5.5mm 55mm
7701-0060 5.5mm 60mm
7701-0065 5.5mm 65mm
7701-0070 5.5mm 70mm
7701-0075 5.5mm 75mm
7701-0080 5.5mm 80mm
7701-0090 5.5mm 90mm
7701-0100 5.5mm 100mm
7701-0110 5.5mm 110mm
7701-0120 5.5mm 120mm
7701-0400 5.5mm 400mm
7701-0500 Rigid 500mm w/ Hex Tips
7701-2500 Malleable 500mm w/ Hex Tips
Titanium Curved Rods, Pre-Cut
Part # Diameter Length
7701-1030 5.5mm 30mm
7701-1035 5.5mm 35mm
7701-1040 5.5mm 40mm
7701-1045 5.5mm 45mm
7701-1050 5.5mm 50mm
7701-1055 5.5mm 55mm
7701-1060 5.5mm 60mm
7701-1065 5.5mm 65mm
7701-1070 5.5mm 70mm
7701-1075 5.5mm 75mm
7701-1080 5.5mm 80mm
7701-1085 5.5mm 85mm
7701-1090 5.5mm 90mm
7701-1095 5.5mm 95mm
7701-1100 5.5mm 100mm
7701-1105 5.5mm 105mm
7701-1110 5.5mm 110mm
22 BIOMET SPINE
SILVERTON® IMPLANTS
Polyaxial Pedicle Screws Auxiliary Tray
Part # Diameter Length
7715-6560 6.5mm 60mm
7715-6570 6.5mm 70mm
7715-6580 6.5mm 80mm
7715-7560 7.5mm 60mm
7715-7570 7.5mm 70mm
7715-7580 7.5mm 80mm
7715-8535 8.5mm 35mm
7715-8540 8.5mm 40mm 7715-8545 8.5mm 45mm 7715-8550 8.5mm 50mm 7715-8555 8.5mm 55mm
7715-8560 8.5mm 60mm
7715-8570 8.5mm 70mm
Variable Cross Connectors
Part # Length
7702-1040 40–45mm
7702-1045 43–50mm
7702-1050 48–60mm
7702-1060 58–80mm
Fixed Cross Connectors
Part # Length
7702-1128 28mm
7702-1131 31mm
7702-1134 34mm
7702-1137 37mm
7702-1140 40mm
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 23
Hooks
Part # Description Part # Description
7720-0508 Hook, Laminar, Narrow Blade, Small
7720-0510 Hook, Laminar, Narrow Blade, Large
7720-0708 Hook, Laminar, Wide Blade, Small
7720-0710 Hook, Laminar, Wide Blade, Large
7721-0707 Hook, Pedicle, Small
7721-0909 Hook, Pedicle, Large
7722-0509 Hook, Extended Body
Monoaxial Pedicle Screws
Part # Diameter Length Part # Diameter Length
7717-4525 4.5mm 25mm
7717-4530 4.5mm 30mm
7717-4535 4.5mm 35mm
7717-4540 4.5mm 40mm
7717-4545 4.5mm 45mm
7717-5530 5.5mm 30mm
7717-5535 5.5mm 35mm
7717-5540 5.5mm 40mm
7717-5545 5.5mm 45mm
7717-5550 5.5mm 50mm
7717-6530 6.5mm 30mm
7717-6535 6.5mm 35mm
7717-6540 6.5mm 40mm
7717-6545 6.5mm 45mm
7717-6550 6.5mm 50mm
7717-6555 6.5mm 55mm
7717-6560 6.5mm 60mm
7717-6570 6.5mm 70mm
7717-6580 6.5mm 80mm
7717-7540 7.5mm 40mm
7717-7545 7.5mm 45mm
7717-7550 7.5mm 50mm
7717-7555 7.5mm 55mm
7717-7560 7.5mm 60mm
7717-7570 7.5mm 70mm
7717-7580 7.5mm 80mm
7717-8530 8.5mm 30mm
7717-8535 8.5mm 35mm
7717-8540 8.5mm 40mm
7717-8545 8.5mm 45mm
7717-8550 8.5mm 50mm
7717-8555 8.5mm 55mm
7717-8560 8.5mm 60mm
7717-8570 8.5mm 70mm
7717-8580 8.5mm 80mm
7717-8590 8.5mm 90mm
7717-8500 8.5mm 100mm
SILVERTON-D® IMPLANTS
7723-0508 Hook, Ramped Blade
7724-0510 Hook, Angled Blade
7725-3507 Hook, Angled, Left
7725-4507 Hook, Angled, Right
7726-3509 Hook, Offset, Left
7726-4509 Hook, Offset, Right
24 BIOMET SPINE
SILVERTON-D® IMPLANTS (CONTINUED)
Polyaxial Reduction Pedicle Screws
Part # Diameter Length Part # Diameter Length Part # Diameter Length
7709-4525 4.5mm 25mm
7709-4530 4.5mm 30mm
7709-4535 4.5mm 35mm
7709-4540 4.5mm 40mm
7709-4545 4.5mm 45mm
7709-4550 4.5mm 50mm
7709-4555 4.5mm 55mm
7709-4560 4.5mm 60mm
7709-4565 4.5mm 65mm
7709-4570 4.5mm 70mm
7709-4575 4.5mm 75mm
7709-4580 4.5mm 80mm
7709-4585 4.5mm 85mm
7709-4590 4.5mm 90mm
7709-4595 4.5mm 95mm
7709-4500 4.5mm 100mm
7709-5525 5.5mm 25mm
7709-5530 5.5mm 30mm
7709-5535 5.5mm 35mm
7709-5540 5.5mm 40mm
7709-5545 5.5mm 45mm
7709-5550 5.5mm 50mm
7709-5555 5.5mm 55mm
7709-5560 5.5mm 60mm
7709-5565 5.5mm 65mm
7709-5570 5.5mm 70mm
7709-5575 5.5mm 75mm
7709-5580 5.5mm 80mm
7709-5585 5.5mm 85mm
7709-5590 5.5mm 90mm
7709-5595 5.5mm 95mm
7709-5500 5.5mm 100mm
7709-6525 6.5mm 25mm
7709-6530 6.5mm 30mm
7709-6535 6.5mm 35mm
7709-6540 6.5mm 40mm
7709-6545 6.5mm 45mm
7709-6550 6.5mm 50mm
7709-6555 6.5mm 55mm
7709-6560 6.5mm 60mm
7709-6565 6.5mm 65mm
7709-6570 6.5mm 70mm
7709-6575 6.5mm 75mm
7709-6580 6.5mm 80mm
7709-6585 6.5mm 85mm
7709-6590 6.5mm 90mm
7709-6595 6.5mm 95mm
7709-6500 6.5mm 100mm
7709-7525 7.5mm 25mm
7709-7530 7.5mm 30mm
7709-7535 7.5mm 35mm
7709-7540 7.5mm 40mm
7709-7545 7.5mm 45mm
7709-7550 7.5mm 50mm
7709-7555 7.5mm 55mm
7709-7560 7.5mm 60mm
7709-7565 7.5mm 65mm
7709-7570 7.5mm 70mm
7709-7575 7.5mm 75mm
7709-7580 7.5mm 80mm
7709-7585 7.5mm 85mm
7709-7590 7.5mm 90mm
7709-7595 7.5mm 95mm
7709-7500 7.5mm 100mm
7709-8525 8.5mm 25mm
7709-8530 8.5mm 30mm
7709-8535 8.5mm 35mm
7709-8540 8.5mm 40mm
7709-8545 8.5mm 45mm
7709-8550 8.5mm 50mm
7709-8555 8.5mm 55mm
7709-8560 8.5mm 60mm
7709-8565 8.5mm 65mm
7709-8570 8.5mm 70mm
7709-8580 8.5mm 80mm
7709-8585 8.5mm 85mm
7709-8590 8.5mm 90mm
7709-8595 8.5mm 95mm
7709-8500 8.5mm 100mm
Set Screws
Part # Description
7703-1600 Set Screw
7902-1000 Set Screw, Small
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 25
Rods
Part # Description Size
7701-0500 Rod, Rigid w/ Hex Tips 500mm
7701-2500 Rod, Malleable 500mm w/ Hex Tips
7701-3050 Rod, Template, 500mm Malleable (Disposable)
7701-6500 Rod, Straight 500mm w/ Hex Tips, CoCr
Offset Connectors
Part # Description Size
7702-3015 Offset Connector, Open 15mm
7702-3025 Offset Connector, Open 25mm
7702-3040 Offset Connector, Open 40mm
7702-3140 Offset Connector, Closed 40mm
Rod-To-Rod Connectors
Part # Length
7702-4101 Connector, Parallel, 1x2 7702-4102 Connector, Parallel, Extended Body, 1x2 7702-4201 Connector, Parallel, 2x2
7702-4202 Connector, Parallel, Extended Body, 2x2
7702-4400 Connector, Axial
26 BIOMET SPINE
DEVICE DESCRIPTIONTheSilverton®andSilverton-D®systemsareposteriorattachmentspinalfixationsystemscomposedofananatomicallyscaledseriesofpediclescrews,hooks,longitudinalrods,setscrews,nuts,variousconnectors,dedicatedsurgicalinstrumentsandsterilizationcases.Thecomponentsareusedtobuildaconstructtoprovidestabilizationofspinalsegmentsinthethoracic,lumbarandsacralspinetosupportfusion.TheSilvertonandSilverton-DdevicesarepartoftheBIOMETSpinalFixationSystem,whichoffersthesurgeonavarietyofimplantcomponentsfromwhichtoassembleasuitableconstructaccordingtoeachindividualpatient’sneedsandrequirements.Afterasolidfusionoccurs,thesystemservesnofunctionalpurposeandshouldberemoved.Removalisindicatedbecausetheimplantsarenotintendedtotransferorsupportforcesdevelopedduringnormalactivities.However,anydecisiontoremovethedevicemustbemadebythephysicianandthepatient,takingintoconsiderationthepatient’sgeneralmedicalconditionandthepotentialrisktothepatientofasecondsurgicalprocedure.
INDICATIONS FOR USETheSilvertonandSilverton-Dsystemsareintendedtobeusedtohelpprovideimmobilizationandstabilizationofspinalsegmentsinskeletallymaturepatientsasanadjuncttofusionofthethoracic,lumbar,and/orsacralspine.Thesystemisintendedforusewithautograftorallograft.
TheSilvertonandSilverton-Dsystemsareintendedforposterior,non-cervical(T1–S2/Ilium)pedicleandnon-pediclespinalfixation,toprovideimmobilizationandstabilizationofspinalsegmentsinskeletallymaturepatientsasanadjuncttofusioninthetreatmentofthefollowinginstabilitiesordeformities:degenerativediscdisease(asdefinedbybackpainofdiscogenicoriginwithdegenerationofthediscconfirmedbyhistoryandradiographicstudies);spondylolisthesis;trauma(i.e.,fractureordislocation);spinalstenosis;deformitiesorcurvatures(i.e.,scoliosis,kyphosisand/orlordosis);tumor;pseudarthrosis;andfailedpreviousfusion.
CONTRAINDICATIONSContraindicationsmayberelativeorabsolute.Thechoiceofaparticulardevicemustbecarefullyweighedagainstthepatient’soverallevaluation.Circumstanceslistedbelowmayreducethechanceofasuccessfuloutcome.Contraindicationsinclude,butarenotlimitedto:
•Allergytotitaniumorcobaltchromealloys,orforeignbodysensitivity.Wherematerialsensitivityissuspected,appropriatetestsmustbemadepriortoimplantation.
•Knownorsuspectedinfection/immunesystemincompetence.Acuteorchronicinfectiousdiseasesofanyetiologyorlocalization.
•Anyabnormalitypresentwhichaffectsthenormalprocessofboneremodelingincluding,butnotlimitedto,severeosteoporosis
involvingthespine,boneabsorption,osteopenia,activeinfectionatthesiteorcertainmetabolicdisordersaffectingosteogenesis.
•MorbidObesity.Anoverweightorobesepatientcanproduceloadsonthespinalsystemthatcanleadtofailureofthefixationofthedeviceorfailureofthedeviceitself.
•Anyneuromusculardeficitwhichplacesanunusuallyheavyloadonthedeviceduringthehealingperiod.
•OpenWounds.
•Pregnancy.
•Anyothermedicalorsurgicalconditionwhichwouldprecludethepotentialbenefitofspinalsurgery,suchasthepresenceofcongenitalabnormalities,elevationofsedimentationrateunexplainedbyotherdiseases,elevationofthewhitebloodcell(WBC)count,oramarkedleftshiftintheWBCdifferentialcount.
•Anycaserequiringthemixingofcomponentsfromtwodifferentsystems.
•Anycaserequiringthemixtureofstainlesssteelwithtitanium,orstainlesssteelwithcobaltchromeimplantcomponents.
•Feverorleukocytosis.
•Signsoflocalinfectionorinflammation.
•Previoushistoryofinfection.
•Alcoholismorheavysmoking.
•Senility,mentalillnessorsubstanceabuse,ofaseveritythatthepatientmayignorecertainnecessarylimitationsandprecautionsintheuseoftheimplant,leadingtofailureorothercomplications.
•Anypatientunwillingtofollowpostoperativeinstructions.
•Inadequatetissuecoverageovertheoperativesite.
POSSIBLE COMPLICATIONSPossiblecomplicationsspecifictothedevicemayinclude:
•Earlyorlateimplantbending,breakage,failure,looseningormovement/migration
•Bonefracture
•Allergicreactiontoimplantmaterial
Othergeneralcomplicationsassociatedwithanyspinalsurgicalproceduremayinclude:Non-unionordelayedunion,pseudarthrosis;pain;secondsurgery;bleeding;infection,earlyandlate;tissueornervedamage,includingduraltearsorotherneurologicalproblems;incisionalcomplications;scarformation;damagetobloodvesselsandcardiovascularsystemcompromise;changesinmentalstatus;damagetointernalorgansandconnectivetissue;complicationsduetotheuseofbonegrafting,includinggraftdonorsitecomplications;respiratoryproblems;reactionstoanaesthesiaand/ordeath.
IMPORTANT INFORMATION ON THE SILVERTON® SPINAL FIXATION AND SILVERTON-D® DEFORMITY SYSTEMS
SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 27
WARNINGSThesafetyandeffectivenessofpediclescrewspinalsystemshavebeenestablishedonlyforspinalconditionswithsignificantmechanicalinstabilityordeformityrequiringfusionwithinstrumentation.Theseconditionsaresignificantmechanicalinstabilityordeformityofthethoracic,lumbarandsacralspinesecondarytoseverespondylolisthesis(grades3and4)oftheL5–S1vertebra,degenerativespondylolisthesiswithobjectiveevidenceofneurologicalimpairment,fracture,dislocation,scoliosis,kyphosis,spinaltumorandfailedpreviousfusion(pseudarthrosis).Thesafetyandeffectivenessofthesedevicesforanyotherconditionsareunknown.
Patientswithpreviousspinalsurgeryatthelevelstobetreatedmayhavedifferentclinicaloutcomesthanprevioussurgicaloutcomes.
PRECAUTIONS•TheSilvertonandSilverton-Dimplantsareforsingleuse
only.Neverreuseanyimplantevenifitappearsunmarkedorundamaged.Reuseoftheimplantcomponentsmayresultinreducedmechanicalperformance,malfunctionorfailureofthedevice.Anyimplantimplantedandthenremovedmustbediscarded.Useonlynewimplantsforeachcase.
•Theimplantationofpediclescrewspinalsystemsmustonlybeperformedbyexperiencedspinalsurgeonswithspecifictrainingintheuseofthispediclescrewspinalsystemduetothetechnicallydemandingprocedurepresentingariskofseriousinjurytothepatient.
•Basedonthefatiguetestingresults,thephysician/surgeonmustconsiderthelevelsofimplantation,patientweight,patientactivitylevel,otherpatientconditions,etc.whichmayimpactontheperformanceofthesystem.
•Preoperatively:Thesurgeonmustbefullyconversantwithallaspectsofthesurgicaltechniqueandknowtheindicationsandcontraindicationsofthistypeofimplant.Thesurgeonmusthaveacquaintedhimselfbeforetheoperationwiththespecifictechniqueforinsertionoftheproduct,whichisavailablefromthemanufacturer.Aspartofthepreoperativeexamination,thesurgeonmustcheckthatnobiological,biomechanicalorotherfactorswillaffectthecorrectconductoftheoperationandthepostoperativeperiod.Anappropriaterangeofimplantsizesmustbeavailableatthetimeoftheoperation.
•Intraoperatively:Thecorrectselectionofthetypeandsizeofimplantappropriatetothepatientandthepositioningoftheimplantareextremelyimportant.
•TappingtosizeisrequiredforBIOMETTurretScrewsdiameter8.5mmandlarger.FailuretodosocouldresultindamagetotheBoneScrewDriver.Thismayresultinpatientinjury.
•Failuretoplacethesetscrewasinstructed(goldtopsurfaceisvisiblepriortoinsertion)couldresultinafailureoftheinstrumentationtoproperlylockinplaceasintended.Thismayresultinpatientinjury.
•Postoperatively:Patientsmustbeinformedoftheprecautionstobetakenintheireverydaylifetoguaranteeamaximumimplantservicelife.Itisrecommendedthatregularpostoperativefollow-upisundertakentodetectearlysignsoffailureoftheimplantsandtoconsidertheactiontobetaken.Deteriorationofthedeviceafterboneconsolidationcannotbeconsideredtoconstituteadysfunctionordeteriorationinthecharacteristicsoftheimplants.Theimplantcanberemovedafterbonyhealing.
•TheSilvertonandSilverton-Ddeviceshavenotbeentestedforsafetyandcompatibilityinthemagneticresonance(MR)environment.TheSilvertonandSilverton-DsystemshavenotbeentestedforheatingormigrationintheMRenvironment.
•Mixingofdissimilarmetalscanaccelerateorinitiatethecorrosionprocess.TitaniumcomponentsmustNOTbeusedtogetherinbuildingaconstructthatinvolvesotherimplantmaterials.Titaniumandcobaltchromemaybeusedtogetherwithinthesameconstruct.
IMPORTANT INFORMATION ON THE SILVERTON® SPINAL FIXATION AND SILVERTON-D® DEFORMITY SYSTEMS
NOTES
PRODUCT COMPLAINTS — Communicate suspected deficiencies in product quality, identity, durability, reliability, safety, effectiveness and/or performance directly to BIOMET SPINE by email: [email protected] or phone: 866.956.7579. When filing a complaint, please provide the component name(s), part number(s), lot number(s), your name and address, the nature of the complaint, surgeon name and the date you became aware of the complaint. Sterilize and return all component(s) to your local BIOMET SPINE representative. Notify BIOMET SPINE immediately of an incident resulting in patient death or serious injury.
If further directions for use of this system are needed, contact BIOMET SPINE Customer Service by email: [email protected], phone: 866.378.4195 or fax: 303.443.7501.
All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to BIOMET Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of BIOMET.
This material is intended for health care professionals and the BIOMET sales force. Distribution to any other recipient is prohibited.
For complete product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert.
This technique was prepared in conjunction with a licensed health care professional. BIOMET does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient.
Broomfield, CO • 800.447.3625www.biomet.com • LIT7710-0410.02
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