MAUDE Adverse Event Report: Stryker Leibinger Freiburg LOCKSCREW,AXS,ST,2.0X14MM,5P; Craniofacial bone screw, non-bioabsorbable

Catalog Number	56-20514
Medical Device Problem Code	Loss of Osseointegration (2408)
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: LOCKSCREW,AXS,ST,2.0X14MM,5P
• Common Device Name: Craniofacial bone screw, non-bioabsorbable
• 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: 50911814
• Report Number: 0008010177-2026-00183
• Device Sequence Number: 12094794
• Product Code: DZL
• UDI-Device Identifier: 37613327567367
• UDI-Public: 37613327567367
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: No
• Device Catalogue Number: 56-20514
• Device Lot Number: unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• 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