BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER WRIST FUSION SYSTEM

    MDR report key: 472911 · Received July 16, 2003

    Report

    Report Number
    2028840-2003-00023
    Event Type
    Injury
    Date Received
    July 16, 2003
    Date of Event
    July 8, 2003
    Report Date
    July 15, 2003
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN JULY 2003, K.M.I. WAS NOTIFIED OF THE EXPLANT OF A WRIST FUSION SYSTEM FROM A PT 6 MONTHS AFTER ITS ORIGINAL IMPLANT DATE TO ADDRESS CONTINUOUS, LOW LEVEL PAIN. THE PT ADMITTED TO HAVING SUBJECTED THE OPERATIVE LIMB TO EXTREME STRESS LOADING WITHIN TWO WEEKS OF THE IMPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER WRIST FUSION SYSTEM ORTHOPAEDIC WRIST IMPLANT KWM KINETIKOS MEDICAL, INC. 07-0005 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other