Mandible Reconstruction Module Reference ence Guide

Transcription

1 Mandible Reconstruction Module Reference ence Guide

2 Renowned Quality, Lasting Innovation Our products are derived from a close working partnership with surgeons, physicians and healthcare experts from the entire spectrum of the healthcare field. Products embodying innovation and superior quality have been the foundation of the Stryker and the Leibinger reputations. To be successful, each product must not only provide a solution to the clinical need, it must do so with uncompromising clinical integrity. Stryker is one of the preeminent medical products and services companies in the world. Our focus is on the fundamentals and a relentless attention to details of not only design and manufacture, but also of application and outcomes. The output of our work supports the skills and talents of the medical profession. And because of this we set our standards high and work to surpass our own ambitious goals. Since our inception, Stryker has developed products based on the expressed needs of leading practitioners. Our products are derived from a close working partnership with surgeons, physicians and healthcare experts from the entire spectrum of the healthcare field. That partnership has been at the root of our success for nearly eight decades and will continue to foster success into the future. Helping to Restore Health and Dignity 2

3 Solutions defined by partnership 3

4 Introduction Features Usability Color coded implants and instrumentation One screwdriver blade for 2.0 mm, 2.3 mm and 2.7 mm screws Screw type and screw length markers SmartLoad screw delivery fields facilitate easy loading of the screw by guiding the tip of the screwdriver blade into the head of the screw Laser etching across the top of the plate to aid in top / bottom orientation Plates do not require the use of bending inserts Implants Precontoured reconstruction plates with profile heights of 1.5 mm and 2.8 mm Plates accommodate multiple screw types and diameters Compatibility of plates and screws within modules Cross Pin screw head design that combines the advantages of friction fit, axial guidance and torque transmission implants Instruments Dedicated instrument set SmartLock Polyaxial Locking Screw Technology Encourages a locked screw to plate interface, thereby reducing the risk of hardware related complications caused by loose screws* One Step locking screws with a locking capability up to 10 degrees of angulation in every direction for Locking Plates Polyaxial Drill Guides allow pilot holes to be drilled with an angulation up to 10 degrees in every direction when used with Locking Plates SmartLock Screw with 10 angulation in plate * Knott, P.D., et al. Evaluation of Hardware-Related Complications in Vascularized Bone Grafts with Locking Mandibular Reconstruction Plate Fixation. Arch Otolaryngol Head Neck Surg Dec; 133 (12): SmartLock Screw with 10 angulation in curved plate 4

5 Precontured reconstruction plates, gold Precontured reconstruction plates, silver Color coding of modules, implants and instruments Screw type and length markers SmartLoad screw delivery field Temporary recon screw holder Color coding red and blue for 2.0/2.3 mm screws 5

6 Mandible Reconstruction Plates Indications Primary recon plates (color-coded gold): Are indicated: 1. For the fi xation of microvascular grafts only in a single step reconstruction after resection of a tumor, osteomyelitis or osteonecrosis 2. For the internal fi xation of comminuted mandibular fractures Recon plates (color-coded silver): Are indicated: 1. For bridging continuity defects after resection of a tumor, osteomyelitis, or osteoradionecrosis and the fi xation of: microvascular grafts in a primary reconstruction non-vascularised grafts in a primary reconstruction 2. For bridging a continuity defect prior to secondary reconstruction 3. For the internal fi xation of comminuted mandibular fractures or defects associated with other severe trauma Primary Recon Plates Profile Height: 1.5 mm Straight Plates 11 holes holes

7 27 Hemi Mandibular Plates holes right right left left Recon Plates Profile Height: 2.8 mm Straight Plates 11 holes holes Full Mandibular Plates holes holes holes

8 Hemi Mandibular Plates 6+17 holes right right 6+17 holes left left holes right right 6+17 holes left left 17 8

9 2.0 Mandibular Bone Screws, Cross Pin Example 6.0 mm 2.0 mm 2.0 mm Self-Tapping 2.0 x 6 mm screw / illustrated scale 2:1 5/ea. Pack Length 4/ea. Pack E x 4 mm E x 5 mm E x 6 mm E x 7 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm 2.0 mm Locking 2.0 x 6 mm screw / illustrated scale 2:1 5/ea. Pack Length 4/ea. Pack E x 4 mm E x 5 mm E x 6 mm E x 7 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm 9

10 2.3 Mandibular Bone Screws, Cross Pin Example 6.0 mm 2.3 mm 2.3 mm Self-Tapping 2.3 x 6 mm screw / illustrated scale 2:1 5/ea. Pack Length 2/ea. Pack E x 4 mm E x 6 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm mm Locking 2.3 x 6 mm screw / illustrated scale 2:1 5/ea. Pack Length 2/ea. Pack E x 4 mm E x 6 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm 2.7 Mandibular Bone Screws, Cross Pin 2.7 mm Self-Tapping 2.7 x 5 mm screw / illustrated scale 2:1 5/ea. Pack Length E x 5 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm 10

11 2.7 mm Locking 2.7 x 5 mm screw / illustrated scale 2:1 5/ea. Pack Length E x 5 mm E x 8 mm E x 10 mm E x 12 mm E x 14 mm E x 16 mm E x 18 mm E x 20 mm Screwdriver Blade for 2.0/2.3 mm Screws illustrated scale 1:2 Order No. Description /2.3 mm Screwdriver Blade 11

12 Adjustable Temporary Condylar Device illustrated scale 1:1 illustrated scale 1:3 Order No. Description Order No. Instrument Temporary 3-D adjustable Manipulator for 3-D Prosthesis condylar prosthesis Condyle fastening screws Handle for Manipulator (package of two) Rigid Temporary Condylar Device illustrated scale 1:1 Order No. Description Temporary Condylar Prosthesis, Right Temporary Condylar Prosthesis, Left Condyle Fastening Screws (Package of two) Abrasive Burr, 42 mm, Stryker Shaft End 12

13 Drill Bits for 2.0/2.3 mm Bone Screws illustrated scale 1:1 for Screw Length up to Diameter Total Length Shaft End mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 115 mm Stryker mm 1.6 mm 115 mm Dental mm 1.9 mm 115 mm Stryker mm 1.9 mm 115 mm Dental mm 1.6 mm 85 mm Stryker mm 1.6 mm 85 mm Dental mm 1.9 mm 85 mm Stryker mm 1.9 mm 85 mm Dental mm 1.6 mm 58 mm Stryker mm 1.6 mm 58 mm Dental mm 1.9 mm 58 mm Stryker 13

14 Storage Universal Mandible Reconstruction Module with Inlay Screw type marker Bone Screws Screw type marker Locking Screws Screw diameter marker 2.0 mm Screw diameter marker 2.3 mm Screw diameter marker 2.7 mm 14

15 Instrument Set Mandibular Reconstruction and Mandibular Fixation/Fracture Important Note: The Mandible Fixation / Fracture Instrument Set is also required to perform reconstructive procedures Order No. Description Order No. Description Instrument Tray Reconstruction Recon Bender/Cutter Left Recon Bender/Cutter Right Instrument Tray Mandible Plate/Screw Forceps, Angled Standard Angled Forceps, Locking Roller Bender for Mandibular Plates (Out-of- Plane Bending only) Roller Bender for Recon Plates (In-Plane and Out-of-Plane Bending) Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left Plate/Bone Forceps, Atraumatic Tip, Left Plate/Bone Forceps, Atraumatic Tip, Right Temporary Recon Screw Holder Manipulator for 3-D Prosthesis Universal Drill Guide Handle (for Manipulator) Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle, Revolving/ Rigid Plate Bender/Cutter Right Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid /2.3 mm Screwdriver Blade Universal Mandible Trocar Handle, Fixed Cheek Retractor, Fixed Trocar Trocar Drill Guide for 2.0 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws for Compression Plates Depth Measuring Gauge Order No. Optional Instruments Trocar Drill Guide for 2.0 mm Screws, Eccentric Trocar Drill Guide for 2.3 mm Screws, Eccentric Cheek Retractor, Variable Tap 2.0 mm 15

16 Step-by-Step Guide Please Note! Before proceeding, please read Important Notice on back of brochure. Contour & Application: Primary Recon Plate Step 1 Expose defect and select appropriate template. Step 2 Cut Primary Recon Plate with the right handle (R) in the area labeled CUT. Slide the plate through the cutter from left to right. Cut will take place within the window. Step 3 Contour Primary Recon Plate to match template using benders. Benders include plate pockets to reduce hole deformation. Step 4 Insert drill guide through trocar and drill hole. Step 5 Measure desired screw length using adepth gauge. Step 6 Once plate is in place, remove screws and plate. After mandibular resection, replace prebent plate and screws. 16

17 Contour & Application: Recon Plate Step 1 Expose defect and select appropriate template. Step 2a To cut, lock plate in left handle (L) labeled CUT. Place cutting mechanism in right handle (R) fl ush alongside the plate recess in the left handle. Slide (R) handle up until plate is seated within locking mechanism. Step 2b Once plate is fully seated in the cutting mechanism, rotate counterclockwise to shear plate. Step 3a Contour Recon Plate to match template using benders. Benders include plate pockets to reduce the amount of hole deformation. Step 3b Roller benders can be used for out-of-plane bending. Step 4 Insert drill guide through trocar and drill hole. Step 5 Measure desired screw length using a depth gauge. Step 6 Once plate is in place, remove screws and plate. After mandibular resection, replace prebent plate and screws. 17

18 Ordering Information 2.0 / 2.3 mm Mandibular Reconstruction REF Non-Serile Description REF 4/ea. Pack 2/ea. Pack Modules & Inlays Universal Mand.Recon Module, full size, empty, with inlay Screw type marker Bone Screws Screw type marker Locking Screws Screw diameter marker 2.0 mm Screw diameter marker 2.3 mm Screw diameter marker 2.7 mm Primary Recon Plates, Gold, Profile Height 1.5 mm Primary Mand Recon Plate, Straight, 11 Holes, with Template Primary Mand Recon Plate, Straight, 17 Holes, with Template Primary Hemi Mand Plate, Right, Holes, with Template Primary Hemi Mand Plate, Left, Holes, with Template Recon Plates, Silver, Profile Height 2.8 mm Mand. Recon Plate, Straight, 11 Holes, with Template Mand. Recon Plate, Straight, 17 Holes, with Template Recon Hemi Mand Plate, Right, Holes, with Template Recon Hemi Mand Plate, Left, Holes, with Template Recon Hemi Mand Plate, Right, Holes, with Template Recon Hemi Mand Plate, Left, Holes, with Template Recon Full Mand Plate, Holes, with Template Recon Full Mand Plate, Holes, with Template Recon Full Mand Plate, Holes, with Template /ea. Pack 2.0 mm Self-Tapping Screws, Gold Bone Screw 2.0 x 4 mm Bone Screw 2.0 x 5 mm Bone Screw 2.0 x 6 mm Bone Screw 2.0 x 7 mm Bone Screw 2.0 x 8 mm Bone Screw 2.0 x 10 mm Bone Screw 2.0 x 12 mm Bone Screw 2.0 x 14 mm Bone Screw 2.0 x 16 mm Bone Screw 2.0 x 18 mm Bone Screw 2.0 x 20 mm mm Locking Screws, Grey Locking Screw 2.0 x 4 mm Locking Screw 2.0 x 5 mm Locking Screw 2.0 x 6 mm Locking Screw 2.0 x 7 mm Locking Screw 2.0 x 8 mm Locking Screw 2.0 x 10 mm Locking Screw 2.0 x 12 mm Locking Screw 2.0 x 14 mm Locking Screw 2.0 x 16 mm Locking Screw 2.0 x 18 mm Locking Screw 2.0 x 20 mm mm Self-Tapping Screws, Gold Bone Screw 2.3 x 4 mm Bone Screw 2.3 x 6 mm Bone Screw 2.3 x 8 mm Bone Screw 2.3 x 10 mm Bone Screw 2.3 x 12 mm Bone Screw 2.3 x 14 mm Bone Screw 2.3 x 16 mm Bone Screw 2.3 x 18 mm Bone Screw 2.3 x 20 mm

19 REF Non-Serile Description REF 5/ea. Pack 2/ea. Pack 2.3 mm Locking Screws, Grey Locking Screw 2.3 x 4 mm Locking Screw 2.3 x 6 mm Locking Screw 2.3 x 8 mm Locking Screw 2.3 x 10 mm Locking Screw 2.3 x 12 mm Locking Screw 2.3 x 14 mm Locking Screw 2.3 x 16 mm Locking Screw 2.3 x 18 mm Locking Screw 2.3 x 20 mm mm Emergency Screws, Gold Emergency Screw 2.7 x 5 mm Emergency Screw 2.7 x 8 mm Emergency Screw 2.7 x 10 mm Emergency Screw 2.7 x 12 mm Emergency Screw 2.7 x 14 mm Emergency Screw 2.7 x 16 mm Emergency Screw 2.7 x 18 mm Emergency Screw 2.7 x 20 mm Twist Drill for 2.0/2.3 mm Screws mm working length, 1.6 x 50 mm, Stryker End mm working length, 1.6 x 50 mm, Dental End mm working length, 1.6 x 50 mm, Stryker End mm working length, 1.6 x 50 mm, Dental End mm working length, 1.6 x 115 mm, Stryker End mm working length, 1.6 x 115 mm, Dental End mm working length, 1.9 x 115 mm, Stryker End mm working length, 1.9 x 115 mm, Dental End mm working length, 1.6 x 85 mm, Stryker End mm working length, 1.6 x 85 mm, Dental End mm working length, 1.9 x 85 mm, Stryker End mm working length, 1.9 x 85 mm, Dental End mm working length, 1.6 x 58 mm, Stryker End mm working length, 1.6 x 58 mm, Dental End mm working length, 1.9 x 58 mm, Stryker End REF Non-Serile Description REF Non-Serile Description Instrument Set Mandibular Reconstruction Instrument Tray Reconstruction Recon Bender/Cutter Left Recon Bender/Cutter Right Roller Bender for Recon Plates (Out-of-Plane only) Roller Bender for Recon Plates (in-plane and Out-of-Plane Bending) Plate/Bone Forceps, Atraumatic Tip, Left Plate/Bone Forceps, Atraumatic Tip, Right Temporary Recon Screw Holder Manipulator for 3-D Prosthesis Universal Drill Guide Handle (for Manipulator) Screwdriver Ratchet Handle Screwdriver Handle, Revolving/Rigid / 2.3 / 2.7 mm Screwdriver Blade Temporary Adjustable Condylar Device Temporary 3-D Adjustable Condylar Prosthesis Condyle Fastening Screws Manipulator for 3-D Prosthesis Handle for Manipulator Temporary Rigid Condylar Device Temporary Condylar Prosthesis, Left Temporary Condylar Prosthesis, Right Condyle Fastening Screws Abrasive Burr 42 mm, Stryker-Shaft Instrument Set Mandibular Fracture Instrument Tray Mandible Plate/Screw Forceps, Angled Standard Angled Forceps, Locking Straight Forceps, Standar Straight Forceps, Locking Plate Bender Left Plate Bender/Cutter Right Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid /2.3 mm Screwdriver Blade Universal Mandible Trocar Handle, Fixed Cheek Retractor, Fixed Trocar Trocar Drill Guide for 2.0 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws for Compression Plates Depth Measuring Gauge /2.3 mm Screwdriver Blade, Short, 90 Angled Screwdriver (Luhr-Fritzemeier) Optional Instruments Mandibular Fracture Trocar Drill Guide for 2.0 mm Screws, Eccentric Trocar Drill Guide for 2.3 mm Screws, Eccentric Cheek Retractor, Variable Tap 2.0 mm 19

20 Trauma, Extremities & Deformities Biologics Surgical Products Neuro & ENT Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 D Freiburg Germany Tel.: ++49 (0) Fax: ++49 (0) This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgement when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions including the instructions for cleaning and sterilization (if applicable) before using any Stryker products. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. This document is not for distribution in the USA Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Leibinger, Stryker, SmartLock. All other trademarks are trademarks of their respective owners or holders. The products listed above are CE marked. Literature Number: LOT B0111 Copyright 2011 Stryker Printed in the USA