BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMI TOTAL WRIST IMPLANT

    MDR report key: 1031612 · Received April 18, 2008

    Report

    Report Number
    MW5006300
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    INTEGRA LIFESCIENSES CORPORATION
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, TOTAL WRIST IMPLANT FRACTURED REQUIRING REPAIR. PT RETURNED TO OR FOR DAMAGED HARDWARE TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMI TOTAL WRIST IMPLANT ORTHOPEDIC PRODUCTS KWM INTEGRA LIFESCIENSES CORPORATION KMI UNIVERSAL 2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention