BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 515234 · Received March 8, 2004

    Report

    Report Number
    2028840-2004-00012
    Event Type
    Other
    Date Received
    March 8, 2004
    Date of Event
    February 26, 2004
    Report Date
    March 3, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A 8MM SUBTALAR MBA FOOT IMPLANT FROM A PT TO ADDRESS PAIN REPORTED 8 MONTHS FOLLOWING THE ORIGINAL IMPLANT DATE. NO DEVICE DEFECTS WERE REPORTED. AN INVESTIGATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-0108 7773-8-8153

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other