MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PLT/6HL CVD SAG SPT12MMBAR LOK; IMPLANT

Catalog Number	55-10556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
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 the plate fractured.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: d4, h3, h4, h6 device evaluation: follow-up report submitted to document device evaluation results.The reported breakage could be confirmed according to the visual inspection of the returned devices.The plate failure was caused by overload conditions, with sem analysis revealing both low-cycle fatigue rupture and forced fracture with severe embrittlement.Manufacturing and inspection records showed no issues, and the breakage likely progressed from one side first, reducing stability and leading to complete failure under increased forces.Based on the 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: PLT/6HL CVD SAG SPT12MMBAR LOK
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23037075
• Report Number: 0008010177-2025-00114
• Device Sequence Number: 21287082
• Product Code: JEY
• UDI-Device Identifier: 04546540366252
• UDI-Public: 04546540366252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/11/2025

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: 55-10556
• Device Lot Number: 1000516612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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