BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 604117 · Received May 16, 2005

    Report

    Report Number
    2028840-2005-00005
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    April 27, 2005
    Report Date
    May 16, 2005
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005, KINETIKOS MEDICAL, INC, WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHOPEDIC IMPLANT TO ADDRESS PAIN REPORTED BY THE PT SEVEN WEEKS FOLLOWING THE ORIGINAL IMPLANT DATE. THE DEVICE WAS NOT RETURNED TO KMI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-0XXX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other