BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 2231337 · Received July 25, 2011

    Report

    Report Number
    3008524126-2011-00019
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ORTHOFIX, INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE TIBIAL LENGTHENER WAS IMPLANTED IN THE LEFT FEMUR. THE ISKD LENGTHENER STOPPED DISTRACTING AFTER 1.5 CM OF LENGTHENING. THE LENGTHENER WAS REMOVED AND REPLACED WITH ANOTHER LENGTHENER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LIMB LENGTHENER HSB ORTHOFIX, INC. T12-300-380

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other