BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL WRIST FUSION SYSTEM

    MDR report key: 572650 · Received February 8, 2005

    Report

    Report Number
    2028840-2005-00001
    Event Type
    Other
    Date Received
    February 8, 2005
    Date of Event
    December 1, 2004
    Report Date
    February 8, 2005
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A UNIVERSAL TOTAL WRIST FUSION SYSTEM IMPLANT FROM A PT IN 2004 OWING TO CHRONIC PAIN. THE EXPLANTED COMPONENTS WERE RETURNED TO KMI FOR EVAL IN 2005. NO DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL WRIST FUSION SYSTEM ORTHOPEDIC WRIST IMPLANT HWC KINETIKOS MEDICAL, INC. 26-5000 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other