BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 517084 · Received March 18, 2004

    Report

    Report Number
    2028840-2004-00013
    Event Type
    Other
    Date Received
    March 18, 2004
    Date of Event
    February 25, 2004
    Report Date
    March 17, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004 KINETIKOS MEDICAL, INC. WAS INFORMED OF THE EXPLANT OF AN SUBTALAR MBA FOOT IMPLANT FROM A PT TO ADDRESS PAIN IN THE SUBTALAR REGION 14 MONTHS AFTER ITS ORIGINAL IMPLANT DATE. THE DEVICE WAS NOT RETURNED TO KMI FOR INVESTIGATION. NO DEVICE DEFECTS WERE REPORTED. POST-EXPLANT PROGNOSIS WAS INDICATED AS EXCELLENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other