MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONESCREW,AXS,MP,ST,2.0X6MM,5P; IMPLANT

Catalog Number	56-20706
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
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 patient showed evidence of infection and loose hardware, resulting in revision surgery.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.The reported loosening and infection could not be confirmed because neither the devices were returned nor could laboratory results or an image (loosened devices) be provided.Further information indicated that the initial surgery took place on (b)(6) 2025, followed by a revision on (b)(6) 2025, due to observed loosening of the implants, which was believed to have led to infection, although no x-ray images were available for review.After review, stryker's medical expert concluded that the implants did not cause or contribute to the loosening or infection, but that the loosening was instead due to surgical technique or poor bone density.Based on the investigation, there is no evidence of a malfunctioning product or a problem related to the design, material, or manufacturing.Therefore, no corrective and/or preventive measures are considered necessary at this time.

• Brand Name: BONESCREW,AXS,MP,ST,2.0X6MM,5P
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23532479
• Report Number: 0008010177-2025-00155
• Device Sequence Number: 9140911
• Product Code: JEY
• UDI-Device Identifier: 37613327566865
• UDI-Public: 37613327566865
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 02/12/2026

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: 56-20706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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