The next generation CranIal PlaTIng system

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1 The next generation CranIal PlaTIng system matrixneuro surgical TeChnIque

2 Table of Contents Introduction MatrixNEURO Cranial Plating System 4 MatrixNEURO Reconstruction Mesh 6 MatrixNEURO Preformed Mesh 7 Surgical Technique Technique 8 Product Information MatrixNEURO Plates 13 MatrixNEURO Mesh 16 MatrixNEURO Reconstruction Mesh 18 MatrixNEURO Preformed Mesh 19 Instruments 20 MatrixNEURO Module and Accessories 22 MatrixNEURO Sterile Kit 24 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. MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF

3 MatrixNEURO Cranial Plating System Introduction The 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. Plate and screw osteosynthesis has been established and clinically recognized for some time. Keeping the AO philosophy at its core, MatrixNEURO system is a plating platform for internal fixation of the craniomaxillofacial skeleton addressing neuro, craniofacial, mandibular, and orthognathic surgery. MatrixNEURO system is a streamlined, comprehensive system that offers flexibility, ease of use, and the highest quality implants and instruments. 2 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

4 Warning: Not intended for use in patients who are not yet skeletally mature. Resorbable fixation products should be considered as an alternative. Warning: 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. Caution: 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. MR information The MatrixNEURO Cranial Plating System has not been evaluated for safety and compatibility in the MR environment. The MatrixNEURO Cranial Plating System has not been tested for heating or migration in the MR environment. MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 3

5 matrixneuro Cranial Plating system Indications The depuy synthes matrixneuro Cranial Plating 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. MatrixNEURO Cranial Plating System x low plate/screw profile of 0.5 mm for minimal implant palpability x self-drilling screws for fast closure of bone flaps and rapid fixation of cranial fractures x screwdriver blade provides secure, reliable screw/blade retention MatrixNEURO Self-drilling Screws x unique thread design for rapid screw starting and low insertion torque x available in 3 mm 5 mm lengths x for use with all matrixneuro plates and mesh MatrixNEURO Plates x Plates are only 0.4 mm thick x full selection of titanium plates and burr hole covers MatrixNEURO Ultra Low Profile Plates x low plate/screw profile of 0.4 mm preserves patient cosmesis x Plates are only 0.3 mm thick x Chamfered edges and wide profile for virtually no palpability x Construct stiffness and strength is comparable to matrixneuro plates x Color-coded (light green) for easy identification x for use with matrixneuro self-drilling screws 2 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

6 matrixneuro Cranial Plating system MatrixNEURO Contourable Mesh x available in a variety of shapes and sizes x design allows screw placement through either side of mesh x Color-coded based on strength characteristic: 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid mesh strength gradient MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 2

7 MatrixNEURO Reconstruction Mesh Indications The DePuy Synthes MatrixNEURO Reconstruction Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.* MatrixNEURO Reconstruction Mesh x Our most rigid MatrixNEURO mesh x Single-sided, low 0.6 mm profile x Benders for contouring without kinking x Available in a variety of shapes and sizes for reconstructing cranial defects x For use with MatrixNEURO self-drilling screws x 82% more rigid than MatrixNEURO 0.6 mm Pink Mesh** 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient **Not available for sale in Canada. ** data on file. Bench test results may not necessarily be indicative of clinical performance. 6 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

8 matrixneuro Preformed mesh Indications The depuy synthes matrixneuro Preformed mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.* 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid mesh strength gradient MatrixNEURO Preformed Mesh x Preformed mesh is 82% more rigid than matrixneuro 0.6 mm Pink mesh** x anatomical shapes to fit an average skull x Provides rigid construct for a variety of cranial defect reconstructions x mesh pattern allows for anatomical contouring without kinking x or convenience for use with matrixneuro screws 2x ftp (r/l) 2x Temporal (r/l) 1x universal 1x frontal single-sided design allows for low, 0.6 mm profile note: Three holes at the apex of each implant are not countersunk. **not available for sale in Canada. ** data on file. bench test results may not necessarily be indicative of clinical performance. Kamer, lukas, md, dds, noser hansrudi, Phd, hammer, beat, md, dds; anatomical background for the development of Preformed Cranioplasty Implants; The Journal of Craniofacial surgery, 2013: MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 1

9 Surgical Technique 1 Select Implant Select the appropriate implants listed on pages The MatrixNEURO Cranial Plating System contains a wide variety of plates, burr hole covers, mesh, and screws. Caution When using plates, preformed or reconstruction mesh, ensure countersink holes are facing upward. 2 Size implant (if required) Instruments Cutting Scissors for Mesh Plates, short nose Cutting Scissors for Mesh Plates, long nose Reconstruction Mesh Cutters Implants may be cut and sized to match the patient anatomy. Reconstruction and Preformed Mesh can only be cut with Reconstruction Mesh Cutters Replace worn or damaged cutting instruments if the cutting function is not adequate. Caution: Cut the implant close to the edge of the screw holes to protect soft tissue from trimmed edges. 8 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

10 Surgical Technique 3 Contour implant (if required) Instruments Mini Plate Bender, locking Mini Plate Bender, non-locking Recon Mesh Benders The implant can be contoured to match the patient s anatomy. Caution: Excessive and repetitive bending of the implant increases the risk of implant breakage. 4 Position implant Instruments Mini Plate Holder, short Mini Plate Holder, long Position the implant on the desired location using the appropriate plate holder. MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 9

11 Surgical Technique 5 Pre-drill screw holes (optional) Instruments mm Drill Bit, hex coupling, 4 mm stop, 52 mm mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm Caution: DePuy Synthes CMF recommends predrilling in dense bone when using 5 mm screws. Always drill with the proper level of irrigation and use the power tool manufacturer s recommended drilling speed to minimize the risk of necrosis or over-drilling. Caution: Use only a 1.1 mm drill bit for predrilling. 6 Secure implant Instruments matrixneuro Screwdriver Blade, hex coupling, self-retaining, short matrixneuro Screwdriver Blade, hex coupling, self-retaining, medium Screwdriver Handle, hex coupling, small screwdriver Handle, hex coupling, medium 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. 11 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

12 Surgical Technique For optimal plate/screw profile, insert the screw perpendicular to the plate in the appropriate plate hole. If the self-drilling screw does not obtain purchase, replace it with a MatrixNEURO 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. MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 11

13 Surgical Technique Technique Tip Secure the implants to the bone flap before positioning the bone flap on the patient 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. DePuy Synthes CMF 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. 2 Caution: After implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

14 MatrixNEURO Plates (shown actual size) Titanium MatrixNEURO Burr Hole Cover, 17 mm, blue also available in 12 mm, 15 mm, and 24 mm, see page Titanium MatrixNEURO Burr Hole Cover, 17 mm, for shunt, blue also available in 12 mm, 15 mm, and 24 mm, see page Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, blue also available in 2 holes, 9 mm, see page Titanium MatrixNEURO Straight Plate, 4 holes, blue Titanium MatrixNEURO X-Plate, blue Titanium MatrixNEURO Box Plate, 14 mm x 14 mm, blue also available in 10 mm x 16 mm and 16 mm x 16 mm, see page 25 MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 11

15 matrixneuro Plates (shown actual size) Titanium matrixneuro y-plate, 5 holes, blue Titanium matrixneuro double y-plate, 6 holes, 18 mm, blue also available in 6 holes, 21 mm, see page Titanium matrixneuro adaption Plate, 7 holes, blue also available in 5 holes and 20 holes, see page Titanium matrixneuro strut Plate, 2 x 3 holes, blue also available in 2 x 4 holes, see page Titanium matrixneuro Curved strut Plate, 2 x 4 holes, blue also available in 2 x 3 holes, see page Titanium ultra low Profile matrixneuro burr hole Cover, 12 mm diameter, light green also available in 15 mm, 17 mm, and 24 mm, see page Titanium ultra low Profile matrixneuro burr hole Cover, 17 mm diameter, for shunt, light green 12 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

16 matrixneuro Plates (shown actual size) Titanium ultra low Profile matrixneuro straight Plate, 2 holes, 9 mm, light green also available in 12 mm and 4 holes, see page Titanium ultra low Profile matrixneuro X-Plate, light green Titanium ultra low Profile matrixneuro box Plate, 14 mm x 14 mm, light green Titanium ultra low Profile matrixneuro double y-plate, 6 holes, 18 mm, light green Titanium ultra low Profile matrixneuro box Plate, 10 mm x 16 mm, light green Titanium ultra low Profile matrixneuro strut Plate, 2 x 3 holes, light green MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 12

17 MatrixNEURO Mesh (shown actual size) 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient Titanium MatrixNEURO Strut Mesh, silver, malleable Titanium MatrixNEURO Temporal Mesh, medium, silver, malleable Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, silver, 0.4 mm malleable also available in other shapes and sizes, see page Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, blue, 0.4 mm rigid also available in other shapes and sizes, see page Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, pink, 0.6 mm rigid also available in other shapes and sizes, see page DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

18 MatrixNEURO Mesh Titanium MatrixNEURO Contourable Mesh, mastoid, small, silver, malleable also available in medium and large, see page 25 MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 11

19 matrixneuro reconstruction mesh 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid mesh strength gradient s Titanium matrixneuro flat reconstruction mesh, square, 100 mm x 100 mm, gold, sterile also available 150 mm x150 mm and 200 mm x 200 mm, see page s Titanium matrixneuro flat reconstruction mesh, round, diameter 70 mm, gold, sterile also available diameter 100 mm, see page DePuy Synthes CMF MATRIXNEURO Surgical Technique

20 MatrixNEURO Preformed Mesh s Ti MatrixNEURO Preformed Mesh 99 mm x 66 mm Temporal, Left Gold-Sterile also available for right side 66 mm 99 mm s Ti MatrixNEURO Preformed Mesh 151 mm x 125 mm FTP, Left Gold-Sterile also available for right side 125 mm 151 mm s Ti MatrixNEURO Preformed Mesh 109 mm x 78 mm Frontal Gold-Sterile 78 mm 109 mm s Ti MatrixNEURO Preformed Mesh 109 mm dia. Universal Gold-Sterile 109 mm MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 11

21 InsTrumenTs matrixneuro screwdriver blade, hex coupling, self-retaining, short matrixneuro screwdriver blade, hex coupling, self-retaining, medium mini Plate bender, locking mini Plate bender, nonlocking mesh Cutting scissors, short nose also available in long nose reconstruction mesh benders reconstruction mesh Cutters 21 DePuy Synthes CMF MATRIXNEURO Surgical Technique

22 Instruments mini Plate holder, long also available in short, see page screwdriver handle with hex coupling, small screwdriver handle with hex coupling, medium screwdriver handle with hex coupling, large mm drill bit, hex coupling, 4 mm stop, 52 mm mm drill bit, stryker J-latch coupling, 4 mm stop, 44.5 mm MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 21

23 Module and Accessories MatrixNEURO Cranial Plating System Module and Accessories matrixneuro Implant and Instrument Set W screw Length Marker, for 3 mm self-drilling screws W screw Length Marker, for 4 mm self-drilling screws W screw Length Marker, for 5 mm self-drilling screws MatrixNEURO Compact Module MatrixNEURO Instrument Module Plate Insert, adjustable, for MatrixNEURO Implant Module Screw Insert, for MatrixNEURO Implant Module Label Sheet for MatrixNEURO Module neuro Insert Tray, for MatrixNEURO Instruments neuro Insert Tray, for MatrixNEURO Instruments and Battery Powered Driver ultra Low Profile Plate Insert, for MatrixNEURO Module ultra Low Profile Label Sheet, for MatrixNEURO Module matrixneuro Strength Gradient Label Sheet (top) (fits in ) (bottom) * For detailed cleaning and sterilization instructions, please refer to: In Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments. 22 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

24 MatrixNEURO Cranial Plating System Trays and Accessories Universal Instrument Tray, large, deep * Neuro Instrument Tray Lid, large screw Insert, for MatrixNEURO Implant Module (shown installed in module ) Neuro Insert Tray, for MatrixNEURO Instruments Universal Instrument Tray, large, deep * Neuro Instrument Tray Lid, large Plate Insert, adjustable, for MatrixNEURO Implant Module (shown installed in module ) neuro Insert Tray, for MatrixNEURO Instruments and BPD universal Instrument Tray, extra large, deep * Neuro Instrument Tray Lid, extra large Neuro Insert Tray, for Cranial Clamps neuro Insert Tray, for MatrixNEURO Instruments and BPD Instrument Insert for Tray matrixneuro Strength Gradient label sheet Instrument Case for MatrixNEURO Mesh (includes lid and Instrument Insert) * Lids not shown MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 22

25 MatrixNEURO Sterile Kit MatrixNEURO Sterile Kit x Ready-to-use sterile packs for one standard craniotomy closure x Simplified ordering x Plate/screw profile of 0.5 mm for minimal implant palpability x MatrixNEURO self-drilling screw for rapid and easy insertion s matrixneuro Sterile Kit, Standard, 4 mm Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, 3/pkg Titanium MatrixNEURO Screw, self-drilling, 4 mm, 6/pkg S matrixneuro Sterile Kit, 17 mm, Burr Hole Cover, 4 mm Titanium MatrixNEURO Burr Hole Cover, 17 mm, 1/pkg Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, 2/pkg Titanium MatrixNEURO screw, self-drilling, 4 mm, 8/pkg. Instruments needed** matrixneuro Screwdriver Blade, hex coupling, self-retaining, medium screwdriver Handle, medium, with hex coupling ** Handles and blades available in additional sizes and lengths, see page DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

26 MatrixNEURO Cranial Plating System Titanium MatrixNEURO Screws self-drilling mm, 5/pkg mm, 5/pkg mm, 5/pkg mm, 20/pkg mm, 20/pkg mm, 20/pkg. emergency mm, 5/pkg mm, 5/pkg mm, 5/pkg. Titanium MatrixNEURO Ultra Low Profile Plates Straight Plate, 2 holes, 9 mm, light green straight Plate, 2 holes, 12 mm, light green Straight Plate, 4 holes, light green X-Plate, light green Box Plate, 14 mm x 14 mm, light green double Y-Plate, 6 holes, 18 mm, light green Box Plate, 10 mm x 16 mm, light green Strut Plate, 2 x 3 holes, light green Titanium MatrixNEURO Plates straight Plate, 2 holes, 9 mm, blue straight Plate, 2 holes, 12 mm, blue straight Plate, 4 holes, 24 mm, blue X-Plate, blue box Plate, 14 mm x 14 mm, blue box Plate, 16 mm x 16 mm, blue box Plate, 10 mm x 16 mm, blue y-plate, 5 holes, blue double Y-Plate, 6 holes, 18 mm, blue double Y-Plate, 6 holes, 21 mm, blue adaption Plate, 5 holes, blue adaption Plate, 7 holes, blue adaption Plate, 20 holes, blue strut Plate, 2 x 3 holes, blue strut Plate, 2 x 4 holes, blue Curved Strut Plate, 2 x 3 holes, blue Curved Strut Plate, 2 x 4 holes, blue Titanium MatrixNEURO Ultra Low Profile Burr Hole Covers Burr Hole Cover, 12 mm, light green Burr Hole Cover, 15 mm, light green Burr Hole Cover, 17 mm, light green Burr Hole Cover, 24 mm, light green burr Hole Cover, 17 mm, for shunt, light green Titanium MatrixNEURO Burr Hole Covers mm, blue mm, blue mm, blue mm, blue mm, for shunt, blue mm, for shunt, blue mm, for shunt, blue mm, for shunt, blue Titanium MatrixNEURO Contourable Mesh 0.4 mm Contourable Mesh Strut Mesh, silver, malleable Temporal Mesh, medium, silver, malleable Mastoid, small, silver, malleable Mastoid, medium, silver, malleable Mastoid, large, silver, malleable Titanium MatrixNEURO Contourable Mesh 0.6 mm Rigid Mesh mm x 45 mm, pink mm x 100 mm, pink mm x 200 mm, pink S 200 mm x 200 mm, pink, sterile Small arc, pink Large arc, pink mm diameter, pink mm diameter, pink mm diameter, pink MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 22

27 MatrixNEURO Cranial Plating System Titanium MatrixNEURO Contourable Mesh 0.4 mm Rigid Mesh mm x 45 mm, blue mm x 100 mm, blue mm x 200 mm, blue Small arc, blue Large arc, blue mm diameter, blue mm diameter, blue mm diameter, blue 0.4 mm Malleable Mesh mm x 45 mm, silver mm x 100 mm, silver Small arc, silver Large arc, silver mm diameter, silver mm diameter, silver mm diameter, silver MatrixNEURO Instruments matrixneuro Screwdriver Blade, hex coupling, self-retaining, short matrixneuro Screwdriver Blade, hex coupling, self-retaining, medium mini Plate Bender, locking mini Plate Bender, nonlocking mini Plate Holder, short mesh Cutting Scissors, short nose mini Plate Holder, long mesh Cutting Scissors, long nose Reconstruction Mesh Benders Reconstruction Mesh Cutters screwdriver Handle with hex coupling, small screwdriver Handle with hex coupling, medium screwdriver Handle with hex coupling, large mm Drill Bit, hex coupling, 4 mm stop, 52 mm mm Drill Bit, Stryker J-Latch, 4 mm stop, 44.5 mm 22 DePuy Synthes CMF MatrixNEURO Cranial Plating System Surgical Technique

28 MatrixNEURO Cranial Plating System Titanium MatrixNEURO Reconstruction Mesh 0.6 mm Rigid Mesh s 100 mm x 100 mm, gold, sterile s 150 mm x 150 mm, gold, sterile s 200 mm x 200 mm, gold, sterile s 70 mm diameter, gold, sterile s 100 mm diameter, gold, sterile Titanium MatrixNEURO Preformed Mesh 0.6 mm Rigid Mesh S 99 mm x 66 mm Temporal Left, Sterile S 99 mm x 66 mm Temporal Right, Sterile S 151 mm x 125 mm FTP Left, Sterile S 151 mm x 125 mm FTP Right, Sterile S 109 mm x 78 mm Frontal, Sterile S 109 mm dia. Universal, Sterile MatrixNEURO Cranial Plating System Surgical Technique DePuy Synthes CMF 22

29 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 CMF 1302 Wrights lane east West Chester, Pa Telephone: (610) To order: (800) fax: (610) Legal Manufacturer (Canada): Synthes (Canada) Ltd meadowpine boulevard mississauga, ontario l5n 6P9 Telephone: (905) To order: (800) fax: (905) depuy synthes Cmf, a division of doi all rights reserved. dsus/cmf/0414/0015(1) 6/14

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