BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 520207 · Received April 2, 2004

    Report

    Report Number
    2028840-2004-00014
    Event Type
    Other
    Date Received
    April 2, 2004
    Date of Event
    March 18, 2004
    Report Date
    April 2, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC. WAS INFORMED OF THE EXPLANT OF SUBTALAR MBA FOOT IMPLANTS FROM A PT TO ADDRESS PAIN IN THE SUBTALAR REGION 4 YEARS AFTER THEIR ORIGINAL IMPLANT DATES. THE DEVICES WERE NOT RETURNED TO KMI FOR INVESTIGATION. NO DEVICE DEFECTS WERE REPORTED. POST-EXPLANT PROGNOSIS WAS INDICATED AS GOOD. USING THE LIMITED INFO PROVIDED, AN INVESTIGATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HWC KINETIKOS MEDICAL, INC. 05-01XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other