MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/RECON, HEMI, MAND; PLATE, BONE

Catalog Number	55-28922
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2026
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 the reconstruction plate broke 6 month after surgery.

• Brand Name: PLT/RECON, HEMI, MAND
• 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: 25313719
• Report Number: 0008010177-2026-00069
• Device Sequence Number: 13389807
• Product Code: JEY
• UDI-Device Identifier: 04546540356444
• UDI-Public: 04546540356444
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 55-28922
• Device Lot Number: 1000575664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/28/2026
• 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