BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 522810 · Received April 27, 2004

    Report

    Report Number
    2028840-2004-00016
    Event Type
    Other
    Date Received
    April 27, 2004
    Date of Event
    April 15, 2004
    Report Date
    April 27, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN APRIL 2004, KINETIKOS MEDICAL, INC. WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHODEPEDIC FOOT IMPLANT FROM A PATIENT TO ADDRESS PAIN IN THE SUBTALAR REGION APPROX 5 MONTHS AFTER ITS ORIGINAL IMPLANT DATE. THE DEVICE WAS NOT 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 HWC KINETIKOS MEDICAL, INC. 05-0XX0 (NI) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other