MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-1PLATE; IMPLANT

Catalog Number	78-92001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Difficulty Chewing (4522)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
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
It was reported that a custom plate is fractured.
Additional Manufacturer Narrative
Update: b5, d9, h6.The returned plate fragments confirmed a postoperative plate fracture, with visual and sem analyses indicating high bending forces, low cycle fatigue, and a forced fracture likely caused by prolonged stress due to persistent non-healing.Since the plate had been under functional stress for approximately one year¿well beyond the intended support period of 2¿3 months¿and one fragment had already fractured, the remaining plate section was subjected to increased stress, resulting in further fractures.Based on the investigation, there are no indications of a incorrectly working product or problems with the design, material, or manufacturing.Therefore, no corrective and/or preventive measures are considered necessary at this time.
Event or Problem Description
No new information.

• Brand Name: FACIAL ID-ORTHOG-1PLATE
• Common Device Name: IMPLANT
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23356907
• Report Number: 0008010177-2025-00137
• Device Sequence Number: 9202283
• Product Code: JEY
• UDI-Device Identifier: 07613327370782
• UDI-Public: 07613327370782
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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?: Yes
• Device Catalogue Number: 78-92001
• Device Lot Number: 2407091003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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