BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 6079964 · Received November 4, 2016

    Report

    Report Number
    0008031020-2016-00536
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. (B)(4). DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    SURGEON ALERTED REP REGARDING HARDWARE FAILURE OF AN ANKLE FUSION, THE NAILS. SURGEON INDICATED THE PATIENT MAY TRY TO SUE STRYKER. NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731468 UNKNOWN_SELZACH_PRODUCT IMPLANT HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other