MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONESCREW,AXS,ST,2.0X5MM,5P; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number	56-20405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device needs to be revised because the joint is not seated and the sagital split plate is mobile.
Additional Manufacturer Narrative
The reported moved plate and screw can be confirmed according to the scans provided for the custom orthognathic plate.It was reported that a sagittal split plate likely became unstable due to loose screw fixation resulting in plate movement and malalignment with associated open bite and pain while a fistula was present without identified organism.Scans indicated that a 6 hole plate was used and the original plate was removed and replaced with a custom orthognathic plate with increased height to restore alignment.Expert review concluded that the infection was not device related if proper sterilization was performed and the event was therefore classified as an adverse effect.

• Brand Name: BONESCREW,AXS,ST,2.0X5MM,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: 25650733
• Report Number: 0008010177-2026-00085
• Device Sequence Number: 20308984
• Product Code: DZL
• UDI-Device Identifier: 37613327566544
• UDI-Public: 37613327566544
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 56-20405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• 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