SUrGICAL TEChNIqUE

DENTOALvEOLAr BONE FIxATION SySTEMBone and bone graft fi xation and containment

TABLE OF CONTENTS

INTrODUCTION

SUrGICAL TEChNIqUE

PrODUCT INFOrMATION

Dentoalveolar Bone Fixation System 2

Indications and Contraindications 4

Graft Containment with Titanium Mesh 5

Graft Fixation with Bone Screws Only 8

Tenting (Membrane Positioning) with Bone Screws 10

Postoperative Considerations 12

Implants 13

Instruments 13

Modules 13

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF

2 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

DENTOALvEOLAr BONE FIxATION SySTEMBone and bone graft fixation and containment

DePuy Synthes CMF is a global medical device company and a market leader in plates and screws used for bone fixation. We develop, produce, and market products that reflect Swiss precision, and Japanese manufacturing techniques.

The Dentoalveolar Bone Fixation System is a mesh and screw system, manufactured from titanium and titanium alloy. The meshes are available in a variety of configurations to accommodate various dentoalveolar defect sites, and attach to bone via titanium cortex screws.

The Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

These devices are intended for single use only and are offered NONSTErILE only.

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 1

Dentoalveolar Bone Fixation SystemBone and bone graft fi xation and containment

Meshes• Meshes are available for the containment of bone graft

and bone graft substitutes• Meshes contour without kinking to match the irregular

craniofacial anatomy• Manufactured from commercially pure titanium

Screws• Screws are available for fi xation of bone graft, allograft,

or bone graft substitute segments• Screws are available for tenting (membrane fi xation)• PLUSDrIvE® Screws provide excellent screwdriver blade

retention and off-axis insertion• Available in 1.3 mm, 1.5 mm, and 2.0 mm diameters

with self-tapping or self-drilling tips• Self-drilling screws eliminate the need for predrilling,

eliminating a step in screw placement• Manufactured from titanium alloy (Ti-6Al-7Nb)

Modules and Inserts• System components are customized for the individual

offi ce’s needs• Can be sterilized in offi ce autoclaves

4 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

INDICATIONS AND CONTrAINDICATIONS

IndicationsThe Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

ContraindicationsThe Dentoalveolar Bone Fixation System is not intended for use in full load-bearing applications unless used in conjunction with traditional rigid fixation.

Warnings:• These devices can break during use (when

subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the patient, the broken part should be removed.

• Instruments and screws may have sharp edges or moving joints that may pinch or tear user’s glove or skin.

Precautions:• Drill rate should never exceed 1,800 rpm. Higher

rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of the screws stripping in bone, and/or suboptimal fixation.

• Always irrigate during drilling.• Avoid drilling over nerve or tooth roots.• Take care while drilling as to not damage, entrap,

or tear a patient’s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials.

• Handle devices with care and dispose worn bone cutting instruments in a sharps container.

MR InformationThis device has not been evaluated for safety and compatibility in the Mr environment. This device has not been tested for heating or migration in the Mr environment.

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 5

GrAFT CONTAINMENT WITh TITANIUM MESh

2Select and cut mesh

Instrument

391.952 Mesh Cutter

Select the appropriate mesh size depending on the size of the defect. Cut the mesh to the desired shape using the mesh cutter.

3Prepare bone graft material and fi ll defect

Prepare the bone graft material as directed by the manufacturer’s labeling. Perforate the native cortical bone, if desired, to promote bleeding and vascularity to the bone graft site. Pack bone graft material into the defect.

1Expose defect

Create a fl ap to release the mucosa and expose the dentoalveolar defect.

6 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

Graft Containment with Titanium Mesh

4Contour mesh

Instruments

347.964 Combination Bending Pliers, for 1.0 mm/2.0 mm plates

391.965 Combination Bending/Cutting Pliers, for 1.0 mm–2.0 mm plates

Contour the mesh by placing it onto the bone and bending the mesh to the desired shape.

5Secure mesh

Instruments

311.005 Screwdriver handle, with hex coupling, small

313.254 1.5 mm/2.0 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.5 and 2.0 mm systems)

313.805 1.3 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.3 mm system)

316.238 1.0 mm Drill Bit, mini quick coupling, 50 mm

317.238 1.1 mm Drill Bit, mini quick coupling, 55 mm

Secure the mesh screen to the bony anatomy by placing two to four bone fi xation screws through the mesh into the native bone. • When implanting a 1.3 mm mesh, use 1.3 mm titanium

cortex screws.• When implanting a 1.5 mm mesh, use 1.5 mm titanium

cortex screws.

Important: Before implanting 1.3 mm or 1.5 mm self-tapping screws, drill a pilot hole using the 1.0 mm drill bit for 1.3 mm screws or the 1.1 mm drill bit for 1.5 mm screws.

Note: Please see Page 4 for Warnings for Instruments and Precautions for Drill Bits

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 7

Graft Containment with Titanium Mesh

6ClosureIf needed, further release the fl ap and gingiva to obtain tension-free primary closure.

7SuturePlace interrupted sutures on either side of the defect, and suture the remaining fl ap using the preferred method of closure.

8HealingAllow the tissue to heal.

9Mesh removal after healing

Instruments

311.005 Screwdriver handle, with hex coupling, small

313.254 1.5 mm/2.0 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.5 and 2.0 mm systems)

313.805 1.3 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.3 mm system)

reopen the surgical site with a crestal incision and a mucoperiosteal fl ap. remove the titanium mesh and screws. release the soft tissue and close with sutures.

8 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

GrAFT FIxATION WITh BONE SCrEWS ONLy

1Harvest graft

harvest the bone graft segment and contour it to fi t in the dentoalveolar defect. As an alternative, an appropriate allograft or bone graft substitute may be used.

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 9

3Stabilize graft

Instruments

311.005 Screwdriver handle, with hex coupling, small

313.254 1.5 mm/2.0 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.5 and 2.0 mm systems)

313.805 1.3 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.3 mm system)

Insert the selected titanium cortex screw into the prepared site.

4Closure

release the soft tissue and close with sutures.

GrAFT FIxATION WITh BONE SCrEWS ONLy

2Lag graft to defect

Prepare the site for fixation. Drill a gliding hole through the graft. Drill the screw pilot hole concentric to the gliding hole and countersink the gliding hole to make the screw head flush with the bone graft.

Gliding hole and pilot hole diameters are listed with their corresponding screw sizes below:

Screw Diameter Gliding hole Gliding hole Drill Pilot hole Pilot hole Drill (mm) Diameter (mm) Part Number Diameter (mm) Part Number

1.3 1.5 317.438 1.0 316.238

1.5 1.5 317.438 1.1 317.238

Note: Please see Page 4 for Warnings for Instruments and Precautions for Drill Bits.

11 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

TENTING (MEMBrANE POSITIONING) WITh BONE SCrEWS

1Expose defect

Create a flap to release the mucosa and expose the dentoalveolar defect.

2Measure defect depth

Measure the depth of the defect using a depth gauge. For adequate purchase, the screw should thread at least 3 mm into the bone at the posterior side of the defect.

3Drill pilot hole

Instrument

317.238 1.1 mm Drill Bit, mini quick coupling, 55 mm

317.438 1.5 mm Drill Bit, mini quick coupling, 75 mm

Drill a 1.1 mm diameter pilot hole (for a 1.5 mm tenting screw) or a 1.5 mm diameter pilot hole (for a 2.0 mm tenting screw) in the center of the defect.

Note: Please see Page 4 for Warnings for Instruments and Precautions for Drill Bits.

4Insert screw

Instrument

311.005 Screwdriver handle, with hex coupling, small

313.254 1.5 mm/2.0 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.5 and 2.0 mm systems)

Insert the appropriate length 1.5 mm or 2.0 mm titanium cortex screw into the pilot hole so that the screw head will be flush with the mucosa.

Important: Do not tighten the screw to sit flush with the native bone.

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 11

5Prepare bone graft material and fill defect

Prepare bone graft material as directed by the manufacturer’s labeling. Pack bone graft material into the defect.

6Apply membrane

Prepare and apply dental membrane as directed by the manufacturer’s labeling.

Tenting (Membrane Positioning) with Bone Screws

12 DePuy Synthes CMF Dentoalveolar Bone Fixation System Surgical Technique

POSTOPErATIvE CONSIDErATIONS

Patients should receive from their doctor appropriate postoperative instructions regarding medications and antibiotics, oral hygiene regimen (including rinsing), diet (soft foods for an appropriate period of time), treatment of swelling and bleeding, and activities which should be avoided following surgery (e.g., smoking, drinking through a straw, strenuous physical activity).

Dentoalveolar Bone Fixation System Surgical Technique DePuy Synthes CMF 11

PrODUCT INFOrMATION

Screws1.3 mm Titanium Cortex PLUSDrIvE Screws, self-tapping (5/pkg)

Length (mm) Length (mm)400.434 4 400.442 12400.436 6 400.444 14400.438 8 400.446 16400.440 10

1.3 mm Titanium Cortex PLUSDrIvE Screws, self-drilling (5/pkg)

Length (mm) Length (mm)400.453 3 400.455 5400.454 4 400.456 6

1.5 mm Titanium Cortex PLUSDrIvE Screws, self-tapping (5/pkg)

Length (mm) Length (mm)400.034 4 400.042 12400.036 6 400.044 14400.038 8 400.046 16400.040 10

1.5 mm Titanium Cortex PLUSDrIvE Screws, self-drilling (5/pkg)

Length (mm) Length (mm)400.054 4 400.056 6400.055 5 400.058 8

2.0 mm Titanium Cortex PLUSDrIvE Screws, self-tapping (5/pkg)

Length (mm) Length (mm)401.041 4 401.046 12401.043 6 401.047 14401.044 8 401.048 16401.045 10

2.0 mm Titanium Cortex PLUSDrIvE Screws, self-drilling (5/pkg)

Length (mm) Length (mm)401.061 4 401.063 6401.062 5 401.065 8

Modules60.503.002 1.3 mm/1.5 mm TwinBox Module with Lid and Inserts60.503.003 1.3 mm/2.0 mm TwinBox Module with Lid and Inserts60.503.004 1.5 mm/2.0 mm TwinBox Module with Lid and Inserts60.503.005 Lid for Box Module60.503.011 Box Base60.503.030 2.0 mm Box Insert60.503.050 1.3 mm Box Module with Lid and Insert60.503.060 1.5 mm Box Module with Lid and Insert

Instruments391.952 Mesh Cutter311.005 Screwdriver handle, with hex coupling, small313.805 1.3 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.3 mm system)313.254 1.5 mm/2.0 mm Screwdriver Blade, hex coupling, self-retaining, PLUSDrIvE, 52 mm (for 1.5 and 2.0 mm systems)347.964 Combination Bending Pliers, for 1.0 mm/2.0 mm plates391.965 Combination Bending/Cutting Pliers, for 1.0 mm–2.0 mm plates316.235 1.0 mm Drill Bit, Stryker J-latch, 35 mm

stop, 60 mm 317.235 1.1 mm Drill Bit, Stryker J-latch, 40 mm

stop, 65 mm 310.153 1.5 mm Drill Bit, Stryker J-latch, 75 mm 316.238 1.0 mm Drill Bit, mini quick coupling, 50 mm 317.238 1.1 mm Drill Bit, mini quick coupling, 55 mm 317.438 1.5 mm Drill Bit, mini quick coupling, 75 mm

Meshes421.102 1.3 mm Titanium Mesh Screen, 15 mm x 25 mm, 0.2 mm thick421.103 1.3 mm Titanium Mesh Screen, 20 mm x 30 mm, 0.2 mm thick421.104 1.3 mm Titanium Mesh Screen, 30 mm x 40 mm, 0.2 mm thick421.099 1.3 mm Titanium Mesh Screen, 100 mm x 100 mm, 0.2 mm thick446.017 1.5 mm Titanium Contourable Mesh Plate, Malleable, 100 mm x 100 mm, 0.4 mm thick

For detailed cleaning and sterilization instructions, please refer to: www.synthes.com/cleaning-sterilization In Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments.

© DePuy Synthes CMF, a division of DOI 2014. All rights reserved. DSUS/CMF/0714/0160 8/14

Some devices listed in this Technique Guide may not have been licensed in accordance with Canadian Law and may not be for sale in Canada. Please contact your Sales Consultant for items approved for sale in Canada.

Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

Rx Only

Not all products are currently available in all markets.

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

www.synthesdento.com

Legal Manufacturer (Canada):Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185