BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 528164 · Received May 28, 2004

    Report

    Report Number
    2028840-2004-00019
    Event Type
    Other
    Date Received
    May 28, 2004
    Date of Event
    May 1, 2004
    Report Date
    May 24, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHODPEDIC FOOT IMPLANT FROM A PATIENT TO ADDRESS PAIN IN THE SUBTALAR REGION. THE DEVICE WAS RETURNED TO KMI FOR INVESTIGATION. NO DEVICE DEFECTS WERE DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-0108 7773

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other