BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 520840 · Received April 12, 2004

    Report

    Report Number
    2028840-2004-00015
    Event Type
    Other
    Date Received
    April 12, 2004
    Date of Event
    April 1, 2004
    Report Date
    April 9, 2004
    Manufacturer
    KINETIKOS MEDICAL INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A 10MM SUBTALAR MBA ORTHOPEDIC FOOT IMPLANT FROM A PT TO ADDRESS PAIN IN THE SUBTALAR REGION APPROX 1 YEAR 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. 05-0110 7524.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other