Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

NCT07245810 | Active Not Recruiting FDA Device

• 1 other identifier: UPC_2023_10_CIP_v 1.0
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 2

Brief Summary

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Conditions

Mandibular Fractures; Facial Fracture; Maxilla Fracture; Orthognathic Surgical Procedures

Keywords

Orthognathic Surgery; Mandibular Reconstruction; Mandibular Fractures; Mandibular Reconstruction* / Methods

Outcome Measures

Primary Outcomes (1)

• Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.

  Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.

  Data collected at a single time point per patient in the course of 18 months.

Secondary Outcomes (11)

• Infection rate

  Data collected at time points from patient medical charts in the course of 18 months.

• Intraoperative complications

  Data collected at a single time point per patient in the course of 18 months.

• Postoperative complications

  Data collected at time points per patient in the course of 18 months.

• Any known adverse events

  Data collected at time points per patient in the course of 18 months.

• Plate failure

  Data collected at time points point per patient in the course of 18 months.

Other Outcomes (19)

• Primary indication for the surgery / diagnosis

  Data collected at a single time point per patient in the course of 18 months.

• Max follow-up time

  Data collected at a single time point per patient in the course of 18 months.

• Surgical approach

  Data collected at a single time point per patient in the course of 18 months.

Interventions

Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery DEVICE

Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified as having had a surgical procedure involving the Subject Device.

You may qualify if:

• Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
• Patients for whom data on the primary outcome variable is available.

You may not qualify if:

• Patients with non-reducible and unstable fractures at the time of surgery
• Patients with fractures of a severely atrophic mandible at the time of surgery
• Patients with active local infections at the time of surgery
• Patients with metal allergies and/or foreign body sensitivity at the time of surgery
• Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
• Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions

Sponsors & Collaborators

• Stryker Craniomaxillofacial: lead

Study Sites (2)

New York Center for Orthognathic and Maxillofacial Surgery

New York, New York, 10022, United States

Location

New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York

New York, New York, 11042, United States

Location

Related Links

• Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.
• Lee, Z. Hye, et al. 2020. "The Latest Evolution in Virtual Surgical Planning: Cus-tomized Reconstruction Plates in Free Fibula Flap M
• Witjes, Max J. H., Rutger H. Schepers, and Joep Kraeima. 2018. "Impact of 3D Virtual Planning on Recon-struction of Mandibular and Maxillary Surgical Defects in Head and Neck Oncology." Current Opinion in Otolaryngology and Head and Neck Surgery.

MeSH Terms

Conditions

Mandibular Fractures; Maxillary Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: November 24, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (2)