BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMI WRIST FUSION SYSTEM

    MDR report key: 407632 · Received July 23, 2002

    Report

    Report Number
    2028840-2002-00027
    Event Type
    Injury
    Date Received
    July 23, 2002
    Date of Event
    July 15, 2002
    Report Date
    July 23, 2002
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 7/23/2002 KMI WAS NOTIFIED OF AN EXPLANTED WRIST FUSION SYSTEM OWING TO NON-UNION AND BROKEN BONE SCREWS. KMI WAS NOT ABLE TO EVALUATE COMPONENTS OR X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMI WRIST FUSION SYSTEM ORTHOPEDIC IMPLANT (WRIST) HRS KINETIKOS MEDICAL, INC. 07-5000 7528

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R