BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 525976 · Received May 17, 2004

    Report

    Report Number
    2028840-2004-00018
    Event Type
    Other
    Date Received
    May 17, 2004
    Date of Event
    May 10, 2004
    Report Date
    May 10, 2004
    Manufacturer
    KINETIKOS MEDICAL INC.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHOPEDIC FOOT IMPLANT FROM A PT 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 HWC KINETIKOS MEDICAL INC. 05-0109 7773

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other