BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMI WRIST FUSION SYSTEM

    MDR report key: 440842 · Received January 31, 2003

    Report

    Report Number
    2028840-2003-00005
    Event Type
    Injury
    Date Received
    January 31, 2003
    Date of Event
    January 28, 2003
    Report Date
    January 30, 2003
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003 KMI WAS NOTIFIED OF THE EXPLANT OF A WFS PLATE AND SCREWS WHEN IT WAS DETERMINED THAT IT HAD FUSED TO WRIST TO THE RADIUS WHERE A SYNTHES PLATE HAD BEEN IMPLANTED.

    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 7318

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R