BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR M.B.A.

    MDR report key: 511912 · Received February 13, 2004

    Report

    Report Number
    2028840-2004-00007
    Event Type
    Other
    Date Received
    February 13, 2004
    Date of Event
    January 30, 2004
    Report Date
    February 6, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN FEB 2004, KINETIKOS MEDICAL, INC. WAS INFORMED OF THE EXPLANT OF A SUBTALAR M.B.A. FOOT IMPLANT FROM A PATIENT SIX MONTHS FOLLOWING ITS ORIGINAL IMPLANT DATE TO ADDRESS PAIN. NO DEVICE DEFECTS WERE REPORTED. THE POST-OPERATIVE PROGNOSIS WAS GOOD. THE DEVICE HAD PERFORMED ITS INTENDED FUNCTION CORRECTING THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR M.B.A. ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other