BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 4911162 · Received July 13, 2015

    Report

    Report Number
    0008031020-2015-00294
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    KWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNK SMART TOE IMPLANT. SIZE 15, ANGLED, CATALOG NUMBER IS NOT KNOWN AT THIS TIME. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    SMART TOE IMPANT ROTATED TO A POSITION COMPLETELY VERTICAL IN THE AXIAL PLANE OF THE 4TH TOE (PROXIMAL AND MIDDLE PHALANX). PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452222 UNKNOWN_SELZACH_PRODUCT IMPLANT KWD STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention