MAUDE Adverse Event Report: Stryker Leibinger Freiburg PLT/5HL/L/2MM ADVC 100D LT STD; Implant

Catalog Number	55-06760
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during screw removal, a metal fragment was observed to fall from a plate hole.The fragment was retrieved using forceps and no retained fragment was reported.

• Brand Name: PLT/5HL/L/2MM ADVC 100D LT STD
• 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: tanja büchel ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50855639
• Report Number: 0008010177-2026-00180
• Device Sequence Number: 9936663
• Product Code: JEY
• UDI-Device Identifier: 04546540365996
• UDI-Public: 04546540365996
• 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
• Report Date (Section B): 09/22/2026

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?: No
• Device Catalogue Number: 55-06760
• Device Lot Number: 1000594563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/22/2026
• 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