BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 523165 · Received April 28, 2004

    Report

    Report Number
    2028840-2004-00017
    Event Type
    Other
    Date Received
    April 28, 2004
    Date of Event
    April 22, 2004
    Report Date
    April 27, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN APR 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 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. 05-0109 7338.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other