A Modular Family of Internal Distraction Devices to Lengthen the Mandibular Body, Ramus, and Cranium Craniomaxillofacial (CMF) Distraction System Surgical Technique

Introduction Indications and Contraindications 2 Surgical Technique Preoperative Planning 5 ■ Mandibular Body Distraction 19 ■ Mandibular Ramus Distraction 32 ■ Mandibular Bone Transport 45 ■ Posterior Cranial Vault Distraction 56 Product Information Implants 75 £ Image intensifier control Craniomaxillofacial (CMF) Distraction System Surgical Technique DePuy Synthes 1

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body, mandibular ramus, and cranium where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only. • The 1.0 mm footplates and screws are intended for neonates and infants under the age of 12 months. • The 1.3 mm footplates and screws are intended for...

General warnings • When selecting patients for treatment with mandibular distraction, the surgeon should take into account any pre-existing conditions such as central apnea, multi-level airway obstruction, severe reflux, or other etiologies of airway obstruction that are not tongue based and would not respond to advancement of the mandible. Patients with these conditions may require a tracheostomy. • When selecting patients for treatment with cranial distraction, the surgeon should take into account any pre-existing conditions such as non-syndromic craniosynostosis that would not be treated as...

Possible adverse events As with all major surgical procedures, risks, side effects, and adverse events can occur. While many possible reactions may occur, some of the most common include: problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, cerebrospinal fluid leak, nerve and/or tooth root damage, injury of critical structures including the brain, dura mater, venous sinuses and other blood vessels, Temporomandibular Joint (TMJ) ankylosis and degeneration, excessive bleeding, damage...

Preoperative planning Determine the post-distraction anatomic goal by conducting an evaluation of the craniofacial pathology and asymmetry through clinical exam, Computerized Tomography (CT) scan, cephalogram and/or panoramic x-ray. Anatomical models may be beneficial in severe cases for selecting appropriate distractor components, determining the location of the osteotomy and placement of the devices, and for pre-bending the footplates. Explain to the patient and/or caregiver before surgery the time needed for the whole treatment (e.g. distraction and consolidation times). When placing the distractors,...

Preoperative Planning Mandible and Cranial Cranial Precautions When placing the distractors, consider and verify: • Planned vector of distraction • Planned length of advancement (consider relapse and overcorrection) • Adequate bone quality and quantity for screw placement. A minimum of three screws is required on each side of the osteotomy. The distractor may be fixed with more than three screws per footplate. If large bone advancement is desired, the distractor with mesh footplate can be used to enable the use of more than three screws per footplate. • Dura mater • Venous sinuses and other blood...

Distractor Assembly 1. Select distractor body Select the appropriate design and length distractor body according to the treatment plan. The design type and maximum length of the distractor is etched onto the laterally facing side of the distractor body. For details on distractor bodies, refer to implant descriptions on page 77. Precaution: To ensure that the soft tissue does not obstruct the activation hex during distraction, the next longer size distractor body and/or extension arm may need to be used. Warning: Ensure all steps of the provided technique are followed. It presents a choking hazard...

Distractor Assembly Surgeon activation instruments Instruments 03.315.001 Surgeon Activation Instrument, 1.7 mm, for CMF Distractor Surgeon activation instrument 03.315.005 Surgeon Activation Instrument, 1.7 mm with U-Joint, for CMF Distractor Proper use of the surgeon activation instruments The surgeon activation instruments are used throughout distractor assembly and procedure to assemble and activate the distractor. To use either surgeon activation instrument to advance the distractor, engage the instrument with the activation hex and rotate counter clockwise (in the direction of the arrow...

There are different steps for attaching the footplates to the AB and BC distractor bodies. 311.005 Screwdriver Handle with Hex Coupling, small 311.006 Screwdriver Handle with Hex Coupling, medium 313.252 1.5 mm/2.0 mm Screwdriver Blade, self-retaining, PlusDrive, 96 mm 313.253 1.5 mm/2.0 mm Screwdriver Blade, self-retaining, PlusDrive, 76 mm Use the 1.5 mm/2.0 mm PlusDrive screwdriver blade to remove the machine screw and collar from the distractor body. Set these aside for later reassembly. Remove the lead screw by sliding it out of the distractor body. Thread the B-style footplate onto the...

Distractor Assembly Thread the A-style footplate onto the opposite end of the lead screw and rotate the footplate clockwise until it reaches the center of the lead screw. An “A” and an arrow are etched on the center of the lead screw to assist in assembling the footplate. Assemble footplates–AB distractor Notes: • Footplates should be aligned parallel to each other at the center of the lead screw. • Footplates should be positioned so that the screw holes point away from one another, as shown to the right. Insert the hex end of the lead screw (the end with the B-style footplate) back into the...