MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-2PLATES; PLATE, BONE

Catalog Number	78-92002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon removed the broken hardware and placed new hardware.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6 correction: d2a the reported plate fracture could not be confirmed because the devices were not returned and no postoperative imaging was available for review.The investigation found no evidence of a manufacturing or design related issue.Available information indicates the plates met all design and manufacturing requirements, and the implants had been in situ for more than one year before revision surgery.Based on the statistical investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: FACIAL ID-ORTHOG-2PLATES
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24661192
• Report Number: 0008010177-2026-00038
• Device Sequence Number: 9344462
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 78-92002
• Device Lot Number: 2411191102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown