BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 719681 · Received November 8, 2005

    Report

    Report Number
    2028840-2005-00010
    Event Type
    Other
    Date Received
    November 8, 2005
    Date of Event
    November 7, 2005
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005 KINETIKOS MEDICAL, INC WAS INFORMED OF THE EXPLANTED OF A 6MM SUBTALAR MBA ORTHOPEDIC IMPLANT TO ADDRESS PAIN REPORTED BY THE PATIENT FIVE(5) YEARS FOLLOWING THE ORIGINAL IMPLAT 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. 05-0106 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other