Low Profi le Neuro Plating SystemSurgical Technique

SystemSurgical TechniqueSurgical Technique

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 1

TABLE OF CONTENTS

INTRODUCTION

SURGICAL TECHNIQUE

PRODUCT INFORMATION

Low Profile Neuro Plating System 2

Technique 5

Low Profile Neuro Plates 10

Low Profile Neuro Mesh 12

Instruments 13

Modules and Trays 15

MR Information The Low Profile Neuro Plating System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Low Profile Neuro Plating System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

2 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

LOW PROFILE NEURO PLATING SYSTEM

IntroductionThe aim of surgical fracture treatment is to reconstruct the bony anatomy and restore its function. According to the AO, internal fixation is distinguished by precise reduction, stable fixation, preservation of blood supply, and early mobilization.1 Plate and screw osteosynthesis has been established and clinically recognized for some time.

The Low Profile Neuro Plating System is a cranial closure system that features low plate/screw profile, wide variety of implants, and modular storage options.

Warnings: • Not intended for use in patients who are not yet

skeletally mature. Resorbable fixation products should be considered as an alternative.

• 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 individual patient, the broken part should be removed.

• Be aware that implants are not as strong as native bone. Implants subjected to substantial loads

may fail.

Precaution: Surgical implants must never be reused. An explanted metal implant must never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which could lead to breakage.

1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 3

LOW PROFILE NEURO PLATING SYSTEM

Featuresx Low plate-and-screw profi le for decreased palpabilityx Self-drilling,* self-retaining screws, with modifi ed

cruciform recess, facilitate rapid replacement of bone fl ap

x Wide variety of low-profi le plates to repair the most common types of bony defects and fractures

x Modular storage options to meet specifi c surgeon needs

0.60 mm 0.75 mm 0.90 mm

Low Profile DePuy Synthes DePuy SynthesNeuro† 1.3 mm 1.5 mm

Low-profi le constructx Variety of plates to meet specifi c patient and

surgeon needs

Low-profi le meshx Available in a wide variety of shapes and sizesx Rigid (0.6 mm thick, silver) and malleable

(0.4 mm thick, blue) meshx Design allows screw placement through either

side of meshx Available nonsterile or sterile-packed

*Self-tapping screws are also available.† Data on file.

IndicationsDePuy Synthes Low Profi le Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

4 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

Low Profile Neuro Plating System

*Self-tapping screws are also available.† Mechanical test data on file at DePuy Synthes. Mechanical test results are not necessarily indicative of clinical performance.

Self-drilling screwsx Screws are self-drilling* for easy, one-step insertionx Made from titanium alloy (Ti-6Al-7Nb)x Modified cruciform recess provides:

– High-torque capacity† – Optimal screw retention for quick and easy insertion of screws† – Low-profile rigid fixation†

x Available in 3 mm–6 mm lengths

Hex coupling screwdriver handlesx Available in 3 sizes, including a large ergonomic handlex Hexagonal coupling for easy blade insertion

and removal

311.006

311.007

311.005

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 5

SURGICAL TECHNIQUE

1Select implant

Select the appropriate implants depending on use. The Low Profile Neuro Plating System contains a wide variety of plates, burr hole covers, mesh, and screws.

Precaution: When using plates, ensure countersink holes are facing upward.

2Size implant (if required)

Instrument

391.952 Mesh Cutter

Implants may be cut and sized to match the patient anatomy.

Replace worn or damaged cutting instruments if the cutting function is not adequate.

Precautions: • Take care to protect soft tissue from trimmed edges. • Replace worn or damaged cutting instruments if

the cutting function is not adequate. • Cut the implant immediately adjacent to the

screw holes.

1 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

3Contour implant (if required)

Instrument

329.14 Universal Bending Pliers (two required)

The implant can be contoured to match the patient’s anatomy.

Precaution: Excessive and repetitive bending of the implant increases the risk of implant breakage.

4Position implant

Instrument

348.98 Plate Holding Forceps, Locking

Position the implant on the desired location using the appropriate plate holder.

Surgical Technique

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 1

Surgical Technique

5Pre-drill screw holes (optional)

Instruments

316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm

316.626 1.1 mm Drill Bit, hex coupling, 6 mm stop, 52 mm

317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm

317.16 1.1 mm Drill Bit, Stryker J-Latch coupling, 6 mm stop, 44.5 mm

6Secure implant

Instruments

313.931 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, short

313.932 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, medium

311.005 Screwdriver Handle, hex coupling, small

311.006 Screwdriver Handle, hex coupling, medium

311.007 Screwdriver Handle, hex coupling, large

To load the screw onto the blade, place the blade perpendicular to the screw in the module and fully insert the blade into the screw recess. The screw should be securely attached to the blade.

Precautions: • DePuy Synthes recommends pre-drilling in dense

bone when using 5 mm or 6 mm screws. 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 screws stripping in bone, and/or suboptimal fi xation.

• Irrigate during drilling to avoid thermal damage to the bone.

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

• Use only a 1.3 mm drill bit for pre-drilling.

8 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

For optimal plate/screw profile, insert the screw perpendicular to the plate/bone in the appropriate plate hole. If the screw does not obtain purchase, replace it with a blue Low Profile Neuro emergency screw of the same length.

Screwdriver shafts are self-retaining. Replace screwdriver shafts if they are worn or damaged, or if retention is not adequate.

Precautions: • Fully engage the shaft perpendicular to the

screw head. • Place the 1.6 mm self-drilling screw perpendicular

to the bone at the appropriate plate hole. Take care not to over tighten the screw.

• In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of the fracture or osteotomy. DePuy Synthes recommends at least three plates when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended.

• After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation.

Surgical Technique

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 9

1

2

3

Notes:• Secure the implants to the bone flap before

positioning the bone flap on the patient.

1. Secure the desired plates to bone flap.2. Position the bone flap.3. Secure the plates to the skull.

In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of a fracture or osteotomy.

Precautions:• DePuy Synthes recommends at least three plates

when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended.

• After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation.

Surgical Technique

10 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

LOW PROFILE NEURO PLATES

421.502 Titanium Low Profi le Neuro Straight Plate, 2 holes, 12 mm

Also available in 2 holes, 9 mm, see page 18

421.510 Titanium Low Profi le Neuro X-Plate, 4 holes

421.511 Titanium Low Profi le Neuro Box Plate,14 mm x 14 mm

Also available in 10 mm x 16 mm and 16 mm x 16 mm, see page 18

421.504 Titanium Low Profi le Neuro Straight Plate, 4 holes

421.525 Titanium Low Profi le Neuro Burr Hole Cover, 12 mm diameter

Also available in 15 mm, 17 mm, and 24 mm, see page 18

421.554 Titanium Low Profi le Neuro Burr Hole Cover, for shunt, 17 mm diameter

Also available in 15 mm, see page 18

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 11

Low Profile Neuro Plates

421.515 Titanium Low Profile Neuro Y-Plate,5 holes

421.516 Titanium Low Profile Neuro Double Y-Plate, 6 holes, 18 mm

Also available in 6 holes, 21 mm, see page 18

421.519 Titanium Low Profile Neuro Adaption Plate, 7 holes

Also available in 5 holes and 20 holes, see page 18

421.523 Titanium Low Profile Neuro Strut Plate,2 x 4 holes

Also available in 2 x 3 holes, see page 18

421.501 Titanium Low Profile Neuro Contourable Strut Plate, 8 holes

12 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

LOW PROFILE NEURO MESH

421.500 Titanium Low Profi le Neuro Temporal Mesh Plate, malleable, medium

421.543 Titanium Low Profi le Neuro Contourable Mesh, 30 mm diameter, silver, 0.6 mm rigid

Also available in other shapes and sizes, see page 18

421.540 Titanium Low Profi le Neuro Contourable Mesh, 30 mm diameter, blue, 0.4 mm malleable

Also available in other shapes and sizes, see page 18

421.546 Titanium Low Profile Neuro Contourable Mesh, mastoid, large, blue, 0.4 mm, malleable

Also available in medium, see page 18

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 13

INSTRUMENTS

313.932 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, medium

329.14 Universal Bending Pliers (two required)

391.952 Mesh Cutter

313.931 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, short

14 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

Instruments

316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm

316.626 1.1 mm Drill Bit, hex coupling,6 mm stop, 52 mm

317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm

317.16 1.1 mm Drill Bit, Stryker J-Latch coupling,6 mm stop, 44.5 mm

311.006 Screwdriver Handle with hex coupling, medium

311.007 Screwdriver Handle with hex coupling, large

348.98 Plate Holding Forceps, locking

311.005 Screwdriver Handle with hex coupling, small

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 15

MODULES AND TRAYS

304.634 Low Profile Neuro Compact Module

304.674 Low Profile Neuro Standard Module

For detailed cleaning and sterilizationinstructions, please refer towww.synthes.com/cleaning-sterilization orsterilization instructions, if provided.

11 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

Modules and Trays

304.760 Universal Instrument Tray, large, deep304.761* Neuro Instrument Tray Lid, large 304.762 Neuro Insert Tray, for instruments

304.760 Universal Instrument Tray, large, deep 304.761* Neuro Instrument Tray Lid, large 304.774 Neuro Insert Tray, for Battery

Powered Screwdriver

*Lids not shown.

304.771 Universal Instrument Tray, extra large, deep

304.772* Neuro Instrument Tray Lid, extra large 304.773 Neuro Insert Tray, for cranial clamps 304.762 Neuro Insert Tray, for instruments

Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 11

LOW PROFILE NEURO SYSTEM

Set, Modules, and Trays145.827 Titanium Low Profile Neuro System304.634 Low Profile Neuro Compact Module 304.634.40 Label Sheet, for Low Profile Neuro Module 304.674 Low Profile Neuro Standard Module304.760 Universal Instrument Tray, large, deep 304.761 Neuro Instrument Tray Lid, large304.762 Neuro Insert Tray, for instruments304.771 Universal Instrument Tray, extra large, deep304.772 Neuro Instrument Tray Lid, extra large304.773 Neuro Insert Tray, for cranial clamps304.774 Neuro Insert Tray, for Battery Powered Screwdriver304.775 Neuro Multi Clamp Insert Tray

Instruments 1.1 mm Drill Bits, hex coupling316.624 4 mm stop316.626 6 mm stop

1.1 mm Drill Bits, Stryker J-Latch317.14 4 mm stop317.16 6 mm stop

1.3 mm Drill Bits, Stryker J-Latch310.133 3 mm stop310.136 4 mm stop310.137 6 mm stop

1.3 mm Drill Bits, hex coupling310.134 3 mm stop310.138 4 mm stop310.139 6 mm stop

Screwdriver Handles with hex coupling311.005 Small311.006 Medium311.007 Large

Low Profile Neuro Cruciform Screwdriver Blades, self-retaining

313.931 Hex coupling, short313.932 Hex coupling, medium313.933 Mini quick coupling, short

329.14 Universal Bending Pliers348.98 Plate Holding Forceps, Locking 391.952 Mesh Cutter

Titanium Low Profile Neuro Screws Low Profile Neuro Screws, self-drilling

(with self-retaining cruciform recess) (5/pkg.)

400.833 3 mm length400.834 4 mm length400.835 5 mm length400.836 6 mm length

Low Profile Neuro Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.)

400.843 3 mm length400.844 4 mm length400.845 5 mm length400.846 6 mm length

Low Profile Neuro Emergency Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.)

400.853 3 mm length400.854 4 mm length400.855 5 mm length400.856 6 mm length

18 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique

Titanium Low Profile Neuro Plates421.501 Contourable Strut Plate, 8 holes421.502 Straight Plate, 2 holes, 12 mm421.503 Straight Plate, 2 holes, 9 mm421.504 Straight Plate, 4 holes421.510 X-Plate, 4 holes421.511 Box Plate, 14 mm x 14 mm, 4 holes421.512 Box Plate, 16 mm x 16 mm, 4 holes421.515 Y-Plate, 5 holes421.516 Double Y-Plate, 6 holes, 18 mm421.517 Double Y-Plate, 6 holes, 21 mm421.518 Adaption Plate, 5 holes421.519 Adaption Plate, 7 holes421.520 Adaption Plate, 20 holes421.521 Box Plate, 10 mm x 16 mm, 4 holes421.522 Strut Plate, 6 holes421.523 Strut Plate, 8 holes

Titanium Low Profile Neuro Burr Hole Covers421.525 12 mm diameter421.526 15 mm diameter421.527 17 mm diameter421.528 24 mm diameter421.553 For shunt, 15 mm diameter421.554 For shunt, 17 mm diameter

◊ Available nonsterile or sterile-packed. Add “S” to product number for sterile product.

Low Profile Neuro System

Titanium Low Profile Neuro Contourable Mesh421.500 Temporal Titanium Mesh Plate,

malleable, medium

0.6 mm Rigid Mesh, silver◊

421.532 38 mm x 45 mm421.534 100 mm x 100 mm421.535 200 mm x 200 mm421.538 Small arc421.539 Large arc421.543 30 mm diameter421.544 70 mm diameter421.545 100 mm diameter

0.4 mm Malleable Mesh, blue◊

421.531 38 mm x 45 mm421.533 100 mm x 100 mm421.536 Small arc421.537 Large arc421.540 30 mm diameter421.541 70 mm diameter421.542 100 mm diameter421.546 Mastoid, large421.547 Mastoid, medium

Limited Warranty and Disclaimer: DePuy Synthes 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.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this surgical technique 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.

Not all products may currently be available in all markets.

© DePuy Synthes 2014–2017. All rights reserved.DSUS/CMF/0414/0067(1) 6/17 DV

Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Manufactured or distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380

To order (USA): 800-523-0322 To order (Canada): 855-946-8999

Note: For recognized manufacturer, refer to the product label.

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