Multiple Pre-, Intra-, and Postoperative Adjustments for Vertical, Horizontal, Sagittal, and Occlusal Vector Control External Midface Distractor System Surgical Technique

Introduction External Midface Distractor System 2 Surgical Technique Distractor Construct—LeFort I and LeFort II 7 Application of Internal Hardware for LeFort I and 8 Distractor Construct—LeFort III and Monobloc 12 Application of Internal Hardware for LeFort III and 13 Monobloc Procedures Optional Technique for Intraoral Fixation—Intraoral Splint 18 Application of External Hardware Product Information Postoperative Considerations 29 Emergency Airway Access 33 MR Information The External Midface Distractor System has not been evaluated for safety and compatibility in the MR environment. It has...

External Midface Distractor System Features and Benefits – Preassembled components for quick device assembly in the OR – Internal hardware options for bone-borne fixation – eadframe design for incremental H medial / lateral (ML) and anterior/ posterior (AP) adjustments – Cranial pin location options for stability of headframe placement – Self-drilling or conical-tipped titanium cranial pins for secure bone engagement 2    DePuy Synthes  External Midface Distractor System  Surgical Technique – Multiple pre-, intra-, and postoperative adjustments for vertical, horizontal, sagittal and occlusal...

System Components Zygomatic footplate and wire fixation screw – The zygomatic footplate and wire fixation screw (available in several lengths) are used for fixation to either the infraorbital or supraorbital rim. – The wire fixation screw can be removed percutaneously after the consolidation phase, avoiding the need for a second surgery. Maxillary footplate assembly – The maxillary footplate assembly consists of a maxillary footplate, a machine screw, a wire fixation clamp, a maxillary rod, and a hex socket head cap screw. – Several maxillary rod styles are available for customization to the...

System Components Cranial pins – Positioning pins are used for initial placement of the headframe assembly on the skull. – Conical-tipped mounting pins, available in two lengths, provide rigid fixation of the headframe assembly to the skull. – Self-drilling mounting pins, available in two lengths, engage the skull by threading into the bone. Vertical rod assembly – The vertical rod assembly is available in non-angulating and angulating configurations. – The vertical rod assembly can be placed anywhere along the central hub of the headframe to precisely align the vertical rod with the patient’s...

System Components Horizontal rod assembly – The horizontal rod assembly is available with rigid clamps or swivel clamps. – Swivel clamps allow postoperative adjustments to achieve three-dimensional control of the mobile segment. – 0 mm distraction arms attach the horizontal rod assembly 4 to the midface segment using stainless steel surgical wire. – Alternative connecting bars are available to customize the horizontal rod assembly to the patient’s anatomy. Horizontal rod assembly, with rigid clamps Horizontal rod assembly, with swivel clamps Headframe adjustment instruments – Headframe adjustment...

The Synthes External Midface Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy, and /or the cranium utilizing a monobloc osteotomy in adult and pediatric populations where gradual bone distraction is required. LeFort I and LeFort II Advancements LeFort III and Monobloc Advancements Warnings: – These devices can break during use (when subjected to excessive forces or outside...

Distractor Construct—LeFort I and LeFort II Advancements 1. Headframe Assembly (390.100) (use 1) 2. Vertical Rod Assemblies (choose 1) – Non-angulating (390.102) – Angulating (390.104) 3. Horizontal Rod Assemblies (choose 1) – Rigid clamps (390.106) – Swivel clamps (390.108) 4. Wire Fixation Clamp (03.307.001) (use 2) 5. Titanium Maxillary Rods (choose 2) – 80 mm (04.307.008) – 80 mm, tall offset (04.307.108) – 110 mm (04.500.000) – 110 mm, tall offset (04.307.111) 6. 1.5 mm Titanium Cortex Screws, self-drilling, with PLUSDRIVE® Screw recess (use a minimum of 6, 3 per footplate) – 5 mm (400.055)...

Application of Internal Hardware for LeFort I and LeFort II Procedures 1 Make intraoral incision Make a maxillary vestibular incision. Elevate the periosteum to expose the maxilla. Precaution: Factors to be considered and verified: – Occlusal plane – Planned length of advancement (consider relapse and overcorrection) – Lip closure – Soft tissue coverage – Patient pain due to distractor interference with soft tissue – Access to the screws based on approach 2 Mark osteotomy Mark the approximate site of the osteotomy. 3 Fit maxillary footplate assemblies Instrument 347.964 Combination Bending Pliers...

Application of Internal Hardware for LeFort I and LeFort II Procedures 4 Contour maxillary rods Instrument 329.18 Bending Pliers Contour the maxillary rods using the bending pliers so that the rods protrude medial to the lip commissures and in a position that does not irritate the lips. Notes: – Etched lines provide a visual guide to simplify the bending process. Bend the rods along the corresponding etched line to enable them to protrude through the lips parallel to the sagittal plane. – A torsional bend may be necessary to achieve the proper position. – Position the wire fixation clamps on...

Application of Internal Hardware for LeFort I and LeFort II Procedures 5 Mark positions of maxillary footplates Instrument 311.005 Screwdriver Handle with Hex Coupling, small Mark the positions of the maxillary footplates before making the osteotomy by inserting two appropriate length screws through each footplate using the 1.5 mm/2.0 mm screwdriver blade. Do not fully tighten the screws. Precautions: – Firmly press the screwdriver blade into the screw recess to ensure retention of the screw on the screwdriver blade. – Take care to avoid nerves, tooth buds and roots, or other critical structures...