MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONESCREW,AXS,ST,2.0X8MM,5P; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number	56-20408
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately six weeks postoperatively, the plate became loose due to screw backout.During revision surgery, a sheared screw head was identified, requiring replacement of the plate and screws.The surgeon attributed the failure to patient bone quality rather than a device related issue.

• Brand Name: BONESCREW,AXS,ST,2.0X8MM,5P
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• 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: 25776149
• Report Number: 0008010177-2026-00093
• Device Sequence Number: 9632942
• Product Code: DZL
• UDI-Device Identifier: 37613327566582
• UDI-Public: 37613327566582
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: 56-20408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/10/2026
• 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