Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up (SMRP)

Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Surgeon iD Mandible Reconstruction Plates

A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Study Overview

• Status: Completed
• Conditions: Mandible Fracture; Mandibular Reconstruction
• Intervention / Treatment: Device: Mandibular Reconstruction

Detailed Description

This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of Stryker's Surgeon iD Mandible Recon Plate when used in the clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively.

Based on a non-inferiority study power calculation a minimum of 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Germany
  • Zwickau, Germany, 08060
    • Heinrich-Braun-Klinikum gGmbH
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Otolaryngology Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Patients who underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice.
2. Patients for whom data on the primary outcome variable is available.

Exclusion Criteria:

1. Patients with active local infections at the time of surgery.
2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
3. Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions.
4. Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.	Rate of unplanned revision surgery determined by reviewing adverse events in patient medical charts after surgery. Used to document whether an unplanned revision surgery was required or not for each patient.	Data collected at a single time point per patient in the course of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate	Determined by adverse events reported from patient medical charts.	Data collected at time points from patient medical charts in the course of 12 months.
Intraoperative complications	Determined by adverse events reported from patient medical charts.	Data collected at a single time point per patient in the course of 12 months.
Postoperative complications	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 12 months.
Any known adverse events	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 12 months.
Rate of Plate failure	Determined by adverse events reported from patient medical charts.	Data collected at time points per patient in the course of 12 months.
Operating room (OR) time	Time patients are operated (hh:mm)	Data collected at a single time point per patient in the course of 12 months.
Time to return to solid food/normal diet	Time for patient to return to solid food/normal diet post operation (dd)	Data collected at a single time point per patient in the course of 12 months.
Rate of satisfactory occlusion achieved with orthodontic treatment.	Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment.	Data collected at time points per patient in the course of 12 months.
Hospitalization time: ICU and normal ward	Time the patient was hospitalized post procedure (dd:hh)	Data collected at a single time point per patient in the course of 12 months.
Short-form-12-health-survey-questionnaire (if available)	Short-form-12-health-survey-Questionnaire (Scale of 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health).	Data collected at time points per patient in the course of 12 months.
Ischemia time	Ischemia time (dd:hh)	Data collected at a single time point per patient in the course of 12 months.
EuroQol-5 Domain Questionnaire (if available)	A descriptive system and a visual analogue scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three to five levels of severity. The VAS provides a subjective rating of overall health on a scale from 0 to 100 (higher is better)).	Data collected at time points per patient in the course of 12 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)	40 independently functioning scales and checklists. Multiple independent scales, each with a 0-100 score, where higher scores indicate better outcomes. Scores are calculated by summing responses on a 4-point Likert scale (e.g., strongly disagree to strongly agree), which are then converted to the 0-100 range. Each scale measures a specific aspect of facial appearance, quality of life, or adverse effects and cannot be summed into a single total score.	Data collected at time points per patient in the course of 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient age	Age (years)	Data collected at a single time point per patient in the course of 12 months.
Primary indication for the surgery / diagnosis	Diagnosis collected from patient medical charts.	Data collected at a single time point per patient in the course of 12 months.
Follow-up time	Post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visit.	Data collected at a single time point per patient in the course of 12 months.
Surgical approach	Surgical approach taken for the procedure. Including: transoral; transbuccal; submandibular; preauricular; other	Data collected at a single time point per patient in the course of 16 months.
Rate of osteotomy	Cases where osteotomy (e.g. BSSO) was performed. Instrumentation used to perform the osteotomy.	Data collected at time points per patient in the course of 12 months.
Frequency of Maxilla-mandibular fixation	Number of maxillo-mandibular fixation procedures (number per patient).	Data collected at time points per patient in the course of 12 months.
Relevant Medical conditions	Descriptive data of any underlying medical conditions and medications recorded in patient medical charts that may be related to the device or primary outcome (qualitative measure).	Data collected at time points per patient in the course of 12 months.
Primary/secondary reconstruction performed	Type of reconstruction procedure performed (e.g. immediately or after an initial surgery).	Data collected at time points point per patient in the course of 12 months
Localization of the defect	Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other	Data collected at time points point per patient in the course of 12 months.
Flap used	Type of flap used: vascularized fibula flap, vascularized scapula flap, vascularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others	Data collected at a single time point per patient in the course of 12 months.
Radiation	Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts. Radiation therapy performed on the anatomical area treated with the device. Any postoperative radiation therapy recorded in patient medical charts.	Data collected at time points per patient in the course of 12 months.
Dental reconstruction in a single stage surgery	Data for dental reconstruction collected from patient medical charts.	Data collected at time points per patient in the course of 12 months.
Sterilization method used	Sterilization method used for the device.	Data collected at a single time point per patient in the course of 12 months.
Fixation system used	System used to fix the device during the procedure. Stryker Universal Mandible System; other Types and number of screws	Data collected at a single time point per patient in the course of 12 months.
Plate types	2.0 or 2.8 plates used, hemi or full reconstruction plate used	Data collected at a single time point per patient in the course of 12 months.
Gender	Responses: Male, Female, undifferentiated, unknown	Data collected at a single time point per patient in the course of 12 months
Patient height	Height (cm, feet, inches)	Data collected at a single time point per patient in the course of 12 months.
Patient weight	Weight (kg, lb)	Data collected at a single time point per patient in the course of 12 months.
Year smoking was stopped	Year smoking was stopped (YYYY)	Data collected at time points per patient in the course of 12 months.
Smoking frequency	The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).	Data collected at time points per patient in the course of 12 month
Smoking duration	Duration of smoking (pack years)	Data collected at time points per patient in the course of 12 month
Years of active smoking	Total number of years active smoker (YY)	Data collected at time points per patient in the course of 12 month

Collaborators and Investigators

• Sponsor: Stryker Craniomaxillofacial

Publications and helpful links

Helpful Links

• Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology.
• Lee,Z. et. al.2020. "The Latest Evolution in Virtual Surgical Planning: Customized Reconstruction Plates in Free Fibula Flap Mandibular Reconstruction." Plastic and Reconstructive Surgery.
• 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.
• Zeller AN, et al. Correction to: Patient-Specific Mandibular Reconstruction Plates Increase Accuracy and Long-Term Stability in Immediate Alloplastic Reconstruction of Segmental Mandibular Defects. J Maxillofac Oral Surg. 2022 Dec;21(4):1096.
• Möllmann HL, et al. Comparison of the Accuracy and Clinical Parameters of Patient-Specific and Conventionally Bended Plates for Mandibular Reconstruction. Front Oncol. 2021 Nov 26;11:719028.
• van Baar, et al, Accuracy of computer-assisted surgery in mandibular reconstruction: A systematic review. Oral Oncol. 2018 Sep;84:52-60. doi: 10.1016/j.oraloncology.2018.07.004. Epub 2018 Jul 20. PMID: 30115476.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: October 24, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures; Dentistry; Oral Surgical Procedures; Orthognathic Surgical Procedures; Mandibular Reconstruction
• Other Study ID Numbers: Surgeon iD Plates _2023_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No