
Surgical Technique Guide

Instructions for Use

Info Sheet
Features & Benefits

Distraction bodies with an anti-reversal mechanism
The distractor bodies are designed with a smooth surface to prevent from pinching or catching on soft tissue during implantation, activation, or removal4.
Anti-reversal mechanism does not require intraoperative locking to prevent backward rotation of the distractor and it can be readily activated in the correct direction by use of the Patient Activation Instrument4-6,12.
Distractor bodies can be activated in both directions by the surgeon by use of the Surgeon Activation Instrument4.

Many footplate options
Footplates, screws and screwdriver blades are color coded to simplify the surgical workflow4,7.
System modularity allows for intraoperative flexibility to accommodate surgeon and patient needs4.

Removable extension arms
Extension arms provide access to point of distractor activation from various distances8.
Rigid and flexible extension arms can be removed after the activation period9.
Flexible extension arms with in-line removal to easily disengage in presence of soft tissue coverage4.10.

Raised head screws
Raised Head Screws and Screwdriver Blades are designed to aid in screw removal from difficult to reach anatomical regions2,7,10.
Raised Head Screws and PLUSDRIVE™ Screws can be used interchangeably.

Patient activation instrument
Patient Activation Instrument designed to prevent unintended device reversal7,8,11.
The Patient Activation Instrument (PAI) and Patient Care Guide (PCG) are designed for ease of use by patients and/or caregivers11.
Animations
TRUMATCH™ CMF Personalized Solutions for preoperative planning
Our total solution seamlessly integrates virtual surgical planning, intraoperative patient-specific tools and personalized implants to help achieve your goals of:
- Accuracy through visualization of anatomy and identification of surgical challenges within a 3D planning environment, intraoperative patient-specific tools to accurately transfer the plan to the OR, and personalized implants14,17,19.
- Efficiency through virtual surgical planning assisted by experienced clinical engineers to optimize preparation, surgical time and the number of procedural steps13,15,17,22.
- Patient Benefit by striving to achieve satisfying aesthetic results and minimizing operative time16,18,20,21,23.
Services and products available for the distraction (see below)*:

Planning session
Live interactive planning session with a knowledgeable team of clinical engineers

Surgical guides
Surgical guides function as cutting and drilling guides to transfer the plan to the operating room

Anatomic models
Anatomic Models for bending distractor footplates
Supporting Documentation

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References
- DePuy Synthes. IMPORTANT INFORMATION ON THE DEPUY SYNTHES CRANIOMAXILLOFACIAL DISTRACTION SYSTEM. 11/19. GP-2535-B. Windchill Document #500054969
- DePuy Synthes. Instructions for Use Craniomaxillofacial (CMF) Distraction System. 21/04/2020, Agile Document# SE_789319_AA.
- DePuy Synthes. 1000+ combinations Memo. A.2, 21/07/2022. Windchill Document #0000318123
- DePuy Synthes. CMFD Relaunch Lab 1 Report. A.120. 23/10/2019. Windchill Document #0000248942
- DePuy Synthes. CMFD and PAI Design Verification Technical Review Minutes. A.8. Apr 2019. Windchill Document #0000282915
- DePuy Synthes. VOC - Features and Benefits of CMFD. A.2. 5/07/2017. Windchill Document #0000268486
- DePuy Synthes. Lab 2 Surgeon Validation Lab Report. A.51. 4/11/2019. Windchill Document #0000261698
- DePuy Synthes. CMFD Relaunch Lab 3 Report. A.58. 04/11/2019. Windchill Document #0000268053
- DePuy Synthes. Cadaver Lab Rigid Extension Arm Validation Report. A.22. Nov 2017 Windchill Document #0000268339
- DePuy Synthes. Craniomaxillofacial (CMF) Distraction System Technique Guide. 12/2019. DSUS/CMF/1114/0248(2)
- DePuy Synthes. PAI End User Validation Report. A.18. 23/10/2019. Windchill Document #0000287979
- Brochures: Zurich II Distraction Concept New horizons in horizontal mandibular distraction, and Distraction Sophisticated Solutions in CMF Surgery, downloaded on 07/09/2020.
- Xia JJ, Phillips CV, Gateno J, Teichgraeber JF, Christensen AM, Gliddon MJ, Lemoine JJ, Liebschner MAK. Cost-Effectiveness Analysis for Computer-Aided Surgical Simulation in Complex Cranio-Maxillofacial Surgery. J Oral Maxillofac Surg. 2006(64): 1780–1784.
- Hsu SS-P, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichfraeber JF, Zhou X, Xia JJ. Accuracy of a Computer-Aided Surgical Simulation Protocol for Orthognathic Surgery: A Prospective Multicenter Study. J Oral
- Maxillofac Surg. 2013; 71(1): 128–142. Saad A, Winters R, Wise MW, Dupin CL, Hilaire HS. Virtual Surgical Planning in Complex Composite Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633.
- Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor TD, Lasky RE, English JD, Kau CH, McGrory KR. Outcome Study of Computer-Aided Surgical Simulation in the Treatment of Patients with Craniomaxillofacial Deformities. J Oral Maxillofac Surg. 2011(69): 2014–2024.
- Rodby KA, Turin S, Jacobs RJ, Cruz JF, Hassid VJ, Kolokythas A, Antony AK. Advances in oncologic head and neck reconstruction: Systematic review and future considerations of virtual surgical planning and computer aided design/computer aided modeling. J Plast Reconstr Aesthet Surg. 2014 Sep; 67(9): 1171–1185.
- Modabber A, Gerressen M, Stiller MB, Noroozi N, Fuglein A, Holzle F, Riediger D, Ghassemi A. Computer assisted mandibular reconstruction with vascularized iliac crest bone graft. Aesth Plast Surg 2012 Jun;36(3):653-659.
- Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB. The accuracy of virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg. 2010 Nov; 68(11):2824-32.
- Leiggener C, Messo E, Thor A, Zeilhofer H.-F, Hirsch J.-M: A selective laser sintering guide for transferring a virtual plan to real time surgery in composite mandibular reconstruction with free fibula osseous flaps. Int. J. Oral Maxillofac. Surg. 2009; 38: 187–192.
- Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-2072
- Ayoub N, Ghassemi A, Rana M, et al. Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial. Trials. 2014;15:114.
- Zhang WB, Yu Y, Wang Y, et al. Improving the accuracy of mandibular reconstruction with vascularized iliac crest flap: Role of computer-assisted techniques. J Craniomaxillofac Surg. 2016;44(11):1819-1827.
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