BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 23437252 · Received October 31, 2025

    Report

    Report Number
    0008031020-2025-02022
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 31, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "A CASE WHERE A PATIENT EXPERIENCED HARDWARE FAILURE AFTER THE INITIAL OPERATION. PLATE HARDWARE LOCKING SCREWS BECAME PROMINENT RESULTING IN HWR SURGERY AND EVENTUALLY A TOTAL KNEE REPLACEMENT ON (B)(6) 2025".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715010 UNKNOWN SCREW SCREW, FIXATION, BONE HWC STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention