Orthodontic Bone Anchor (OBA) System TGsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · The Orthodontic Bone Anchor (OBA) System plate anchors ... If desired,

Orthodontic Bone Anchor (OBA)System. Skeletal implants for theorthodontic movement of teeth.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

Orthodontic Bone Anchor (OBA) System 2

Indications and Contraindications 4

Implanting a Screw Anchor 5

Implanting a Plate Anchor 8

Using Orthodontic Appliances with Plate Anchors 11

Instruments 12

Set List 13

Synthes CMF

Orthodontic Bone Anchor (OBA) System

The Orthodontic Bone Anchor (OBA) System is intended tobe implanted intraorally and used as an anchor for orthodonticprocedures. It includes screw anchors, plate anchors, instru-ments, and a module case for storage and sterilization.

– Provides fixed anchorage for improved control of tooth movement

– Compatible with a variety of orthodontic devices including archwires, elastics and springs

– Allows immediate loading

– Plate anchors can be adapted to the patient’s bony anatomy

– Manufactured from commercially pure (CP) titanium andtitanium alloy* for biocompatibility

Screw anchors– Thread diameter of only 1.55 mm for placement

between tooth roots

– Two through-holes in screwhead accept archwires with a cross section of up to 0.022 in. x 0.028 in.

– Shape of through-holes prevents unintended rotation of rectangular archwires

– Nonthreaded 1.5 mm long gingival collar beneath the screwhead protects soft tissue

– Self-drilling thread lengths of 6 mm and 8 mm, and self-tapping thread length of 10 mm

– Groove in screw anchor head accepts elastics, wires, or springs

2 Synthes CMF Orthodontic Bone Anchor (OBA) System Technique Guide

Through-hole

* Ti-6Al-7Nb

6 mm 8 mm 10 mm

Gingival collar

Plate anchor Screw anchor

Profile of an archwire in a screw anchor

Plate anchors– Allow placement away from

tooth roots

– Can be contoured and/or trimmed to conform to patient anatomy

– Implanted using up to five (5) self-drilling titanium screws for stability

– Three design options

Mesh plate anchorOrthodontists can mount preferreddental bracket to anchors using UV-cure adhesive

Bracket plate anchor Simulates orthodontic bracket and allows attachment of various orthodontic appliances

Domed plate anchorAllows attachment of archwires from three different vectors, or attachment of elastics or springs

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Plate anchor screws– Used to secure plate anchors

to the bone

– Diameter of 1.55 mm

– Lengths of 4 mm, 6 mm, and 8 mm

– Self-drilling threads

Plate anchor emergency screws– Used if a plate anchor screw becomes

loose upon insertion in the bone

– Slightly oversized diameter of 1.85 mm

– Lengths of 4 mm, 6 mm, and 8 mm

– Self-tapping threads

4-hole mesh plate anchor

5-hole mesh plate anchor

4-hole bracket plate anchor

5-hole bracket plate anchor

4-hole domed plate anchor

5-hole domed plate anchor

Indications and Contraindications

IndicationsThe Orthodontic Bone Anchor (OBA) System screw anchorsare intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greaterthan age 12 and adults.

The Orthodontic Bone Anchor (OBA) System plate anchorsare intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

Contraindications– When cortical bone is less than 5 mm thick, or when

there is insufficient quantity or quality of bone

– In deciduous or mixed dentition

– When active or latent infection is present

– In patients with an abnormal habit of mastication, as this may affect the retention and stability of the device after implantation


Implanting a Screw Anchor

1Locate the implantation site

Choose the implantation site according to the treatment objective and the quality and quantity of bone. Confirm that the implantation site allows adequate clearance from the tooth roots.

Choose the screw anchor with the appropriate thread length:6 mm and 8 mm self-drilling or 10 mm self-tapping.

Caution: To avoid damage to anatomic structures, place implant away from tooth roots, tooth buds, vessels, nerves,and/or sinuses. In adolescent patients, care should be takento avoid sutures and other areas and structures that are notfully developed.

2Prepare the implantation site

If desired, make a small incision at the implantation site and dissect through the soft tissue to the bone.

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Preoperative x-ray

Implanting a Screw Anchor continued

3Implant a 6 mm or 8 mm screw anchor

Instruments

03.500.001 Screw Anchor Cruciform Screwdriver Blade,with Spring Holding Sleeve, short

311.007 Screwdriver Handle with hex coupling

Optional instruments

03.500.006 1.25 mm Drill Bit, J-latch, 6 mm stop or 03.500.008 1.25 mm Drill Bit, J-latch, 8 mm stop

Note: To implant a 10 mm self-tapping screw anchor, continue with Steps 4–5.

Using the screw anchor cruciform screwdriver blade withspring holding sleeve, short and the screwdriver handle withhex coupling, load the screw anchor of the desired lengthand implant it until the distal lip of the screw anchor headsits on top of the soft tissue.

If a pilot hole is desired, use the appropriate 1.25 mm drill bit with stop and a surgical power drill. Irrigate thoroughly to prevent overheating of the drill bit and bone.

Note: For optimal retention, insert screw perpendicular to cortical bone.


4Drill a pilot hole for a 10 mm self-tapping screw anchor

Instrument

03.500.010 1.25 mm Drill Bit, J-latch, 10 mm stop

Before implanting a 10 mm self-tapping screw anchor, drill a pilot hole using the 1.25 mm drill bit with 10 mm stop and a surgical power drill. Irrigate thoroughly to preventoverheating of the drill bit and bone.

Important: Always drill a pilot hole for the 10 mm self-tapping screw anchor.

Screw anchor mounted on screwdriver blade with holding sleeve

5Implant a 10 mm self-tapping screw anchor

Instruments

03.500.001 Screw Anchor Cruciform Screwdriver Blade,with Spring Holding Sleeve, short


Using the screw anchor cruciform screwdriver blade withspring holding sleeve, short and the screwdriver handle with hex coupling, implant the 10 mm screw anchor until the distal lip of the screw anchor head sits on top of the soft tissue.


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6Implant additional screw anchors

Repeat the preceding steps for additional screw anchors, as needed.

Caution: Due to clinical limitations associated with orthodontic tooth movement, the applied load should notexceed 300 grams.

Screw anchor mounted on screwdriver blade with holding sleeve

Implanting a Plate Anchor

1Locate the implantation site

Choose the implantation site according to the treatment objective and the quality and quantity of bone. Confirm that the implantation site allows adequate clearance fromthe tooth roots.

Select plate design (mesh pad, bracket or domed).

Consider in advance the reshaping and/or trimming of the plate that may be required to conform to the patient’sbony anatomy.

Caution: To avoid damage to anatomic structures, place implant away from tooth roots, tooth buds, vessels, nerves,and/or sinuses.

2Prepare the implantation site

Make an appropriately sized incision where the plate anchorneck will protrude through the soft tissue, orienting the inci-sion perpendicular to the long axis of the plate anchor neck, and dissect through the soft tissue to the bone. Make a subperiosteal pocket large enough to allow insertion of theplate anchor and implantation of the plate anchor screws.


Preoperative x-ray

3Reshape and/or trim the plate anchor

Instruments

329.14 Universal Bending Pliers

391.98 Plate Cutter

The plate anchor may need to be reshaped and/or trimmed to conform to the patient’s bony anatomy. If so, use the universal bending pliers and/or the plate cutter. The plate anchor has a T-configuration, but it may be trimmed to an L- or I-configuration if required.

If desired, use the universal bending pliers to reshape the plate anchor neck where it will protrude through the soft tissue.

Caution: If contouring is necessary, avoid sharp bends, reverse bends, or bending the implant at a screw hole. Avoid notching or scratching the implant. These factors may produce internal stresses which may become the focalpoint for eventual breakage of the implant.

4Implant the plate anchor screws

Instruments

03.503.202 MatrixMIDFACE Screwdriver Blade

03.500.004– 1.25 mm Drill Bit with stop 03.500.008 (4 mm, 6 mm or 8 mm)


Choose the plate anchor screws of the appropriate length(s).Make certain that they will avoid the tooth roots.

While holding the plate anchor in the desired location in thesubperiosteal pocket, use the MatrixMIDFACE screwdriverblade and the screwdriver handle with hex coupling to implantthe first plate anchor screw.


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Implanting a Plate Anchor continued

4Implant the plate anchor screws continued

Note: If the plate anchor screw becomes loose in the bone,remove the screw and replace it with the appropriate lengthOBA titanium plate anchor emergency screw.

Repeat this process for the remaining screws. It is recom-mended to use at least three (3) screws to secure the plate anchor.

If pilot holes are desired, make one for each screw using theappropriate 1.25 mm drill bit with stop and a surgical powerdrill. Irrigate thoroughly to prevent overheating of the drill bit and bone.

5Confirm stability of plate anchor

Irrigate the subperiosteal pocket until it is free of debris, and surgically close the incision. Confirm that the stability of the plate anchor is satisfactory.

The plate anchor neck is malleable and can be adjusted if necessary.


Using Orthodontic Appliances with Plate Anchors

6aUsing bracket and domed plate anchorsApply orthodontic devices directly to abutment on plate as desired.

6bMounting orthodontic bracket to mesh pad plate anchor

Mount a standard orthodontic bracket to the mesh pad plateanchor using UV-cure adhesive. This will require the same UV-cure adhesive normally used to bond the orthodonticbracket to a tooth.

Apply the UV-cure adhesive directly to the top surface at theend of the mesh pad plate anchor and spread it evenly overthe surface. Add adequate adhesive to the mesh pad of theorthodontic bracket and firmly press the bracket onto thesurface of the plate anchor, adjusting the orientation of thebracket as needed. Excess adhesive may be wiped away fromthe sides and bottom of the mesh pad plate anchor.

Expose the area around the orthodontic bracket and meshpad plate anchor to UV light, using an orthodontic UV lightsource. Time the exposure per the recommendations of the adhesive and UV light source manufacturers.

Caution: Due to clinical limitations associated with orthodontic tooth movement, the applied load should notexceed 300 grams.

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03.500.001 Screw Anchor Cruciform Screwdriver Blade, with Spring Holding Sleeve, short

03.500.004– 1.25 mm Drill Bit, J-latch, 44.5 mm03.500.010 (with 4 mm, 6 mm, 8 mm or 10 mm stop)

391.98 Plate Cutter, for 1.0 mm–2.0 mm plates

03.503.202 MatrixMIDFACE Screwdriver Blade, hex coupling, self-retaining, 76 mm

311.007 Screwdriver Handle with hex coupling, large

329.14 Universal Bending Pliers, for 1.0 mm–2.0 mm plates

Instruments

Orthodontic Bone Anchor (OBA) Set (01.500.006)

Module*60.500.006 Module for Orthodontic Bone Anchor

(OBA) System60.500.007 Label Sheet, Orthodontic Bone Anchor

Instruments03.500.001 Screw Anchor Cruciform Screwdriver

Blade, with Spring Holding Sleeve, short

1.25 mm Drill Bits, J-latch03.500.004 4 mm stop, 44.5 mm03.500.006 6 mm stop, 44.5 mm03.500.008 8 mm stop, 44.5 mm03.500.010 10 mm stop, 44.5 mm

03.503.202 MatrixMIDFACE Screwdriver Blade, hex coupling, self-retaining, 76 mm

311.007 Screwdriver Handle with hex coupling,large

329.14 Universal Bending Pliers, for 1.0 mm–2.0 mm plates, 2 ea.

391.98 Plate Cutter, for 1.0 mm–2.0 mm plates

ImplantsTitanium OBA Screw Anchors, 10 ea.

04.500.006 6 mm length, self-drilling04.500.008 8 mm length, self-drilling04.500.010 10 mm length, self-tapping

Titanium OBA Plate Anchors, mesh pad design, 3 ea.

04.500.014 4 holes04.500.017 5 holes

Titanium OBA Plate Anchors, bracket design, 3 ea.

04.500.012 4 holes04.500.015 5 holes

Titanium OBA Plate Anchors, domed design, 3 ea.

04.500.013 4 holes04.500.016 5 holes

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*Only one screwdriver blade with holding sleeve will fit inside the module at a time.

Titanium OBA Plate Anchor Screws, self-drilling, 2 pkgs. of 5 ea.

04.500.024.05 4 mm length04.500.026.05 6 mm length04.500.028.05 8 mm length

Titanium OBA Plate Anchor Emergency Screws, 2 ea.

04.500.034.01 4 mm length04.500.036.01 6 mm length04.500.038.01 8 mm length

Also Available03.500.002 Screw Anchor Cruciform Screwdriver Blade,

with Spring Holding Sleeve, long03.503.201 MatrixMIDFACE Screwdriver Blade,

hex coupling, self-retaining, 52 mm03.503.203 MatrixMIDFACE Screwdriver Blade,

hex coupling, self-retaining, 96 mm

Note: For additional information, please refer to package insert.

For detailed cleaning and sterilization instructions, please refer tohttp://www.synthes.com/cleaning-sterilization or to the below listed inserts, which will be included in the shipping container:– Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays

and Graphic Cases—DJ1305– Processing Non-sterile Synthes Implants—DJ1304

Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2007 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 6/12 J7581-E

www.synthes.com

Orthodontic Bone Anchor (OBA) System TGsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · The Orthodontic Bone Anchor (OBA) System plate anchors ... If desired,

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