MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-4PLATES; PLATE, BONE

Catalog Number	78-92004
Medical Device Problem Codes	Fracture (1260); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a custom mini plate snapped inside the patient and there was an infection.The doctor removed the plate, washed out the wound, and re-plated the osteotomy using another plate.
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: d6a, d6b, h4, h6.Correction: d2a.The reported plate fracture was confirmed based on the submitted imaging studies.However, the infection could not be confirmed.The patient received facial id plates and temporomandibular joint implants in (b)(6) 2025.A plate fracture occurred postoperatively and was revised in (b)(6) 2025.A review by experts in the fields of design, manufacturing, and medicine found no product related defects or a connection to the infection.Overloading of the plate due to possible non-compliance with postoperative instructions could not be ruled out, and no clear cause was identified.Based on the investigation, there are no indications of a malfunctioning product or of issues related to design, material, or manufacturing.Therefore, no corrective and/or preventive measures are deemed necessary at this time.

• Brand Name: FACIAL ID-ORTHOG-4PLATES
• 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23522486
• Report Number: 0008010177-2025-00153
• Device Sequence Number: 13250596
• Product Code: JEY
• UDI-Device Identifier: 07613327370973
• UDI-Public: 07613327370973
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 78-92004
• Device Lot Number: 2506131056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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