BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 516859 · Received March 15, 2004

    Report

    Report Number
    2028840-2004-00010
    Event Type
    Other
    Date Received
    March 15, 2004
    Date of Event
    March 9, 2004
    Report Date
    March 12, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF 9MM SUBTALAR MBA FOOT IMPLANT FROM A PT TO ADDRESS PAIN IN THE SUBTALAR REGION 23 MONTHS AFTER ITS ORIGINAL IMPLANT DATE. THE DEVICE WAS RETURNED TO KMI FOR INVESTIGATION. NO DEVICE DEFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-1019 7338

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other