BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIDER WRIST FUSION SYSTEM

    MDR report key: 515204 · Received March 8, 2004

    Report

    Report Number
    2028840-2004-00011
    Event Type
    Other
    Date Received
    March 8, 2004
    Date of Event
    February 23, 2004
    Report Date
    March 5, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.,
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A SPIDER WRIST FUSION SYSTEM IMPLANT FROM A PT TO ADDRESS PAIN THAT WAS THE RESULT OF NON-FUSION OF THE CARPAL BONES. NO DEVICE DEFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other