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

Catalog Number	55-10554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 at the screw hole connection site on the proximal side of the plate postoperatively.
Additional Manufacturer Narrative
Update: h6.The reported plate fracture could not be confirmed because the device was not returned to freiburg for examination and no images were provided for review.The customer stated that no x-ray images were available after the initial implantation or from the time when the plate fracture was discovered.It is not known whether the patient followed the aftercare instructions.Based on the investigation, there are no indications of product malfunction or problems related to 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: PLT/6HL CVD SAG SPT,6MMBAR 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23827583
• Report Number: 0008010177-2025-00171
• Device Sequence Number: 20100558
• Product Code: JEY
• UDI-Device Identifier: 04546540366245
• UDI-Public: 04546540366245
• 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): 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: 55-10554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• 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: Other
• Patient Sex: Unknown