BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 2404866 · Received January 3, 2012

    Report

    Report Number
    3008524126-2011-00040
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    July 29, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ORTHOFIX INC
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ISKD LENGTHENER WAS SUBJECTED TO A VISUAL EXAMINATION. THE UNIT WAS DISTRACTED OUT 25MM UPON ARRIVAL FOR FAILURE ANALYSIS. THE UNIT WAS ABLE TO ROTATE AND DISTRACT UNDER HAND MANIPULATIONS. THE UNIT WAS DISASSEMBLED AND THE LEAD SCREW AND NUT WERE FOUND TO BE TORQUE TIGHT. NO DISCREPANCIES WERE NOTED IN THE VISUAL INSPECTION. THE LENGTHENER FUNCTIONED AS INTENDED DURING FAILURE ANALYSIS. THE ROOT CAUSE OF THE STOPPED DISTRACTION COULD NOT BE DETERMINED, ALTHOUGH IT IS POSSIBLE THAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE RESULTANT OBSERVATION SUCH AS PATIENT SELECTION, PATIENT COMPLIANCE OR SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THE ISKD LENGTHENER THAT WAS IMPLANTED STOPPED DISTRACTING DURING TREATMENT. THE ISKD LENGTHENER WAS REMOVED AND REPLACED WITH A NEW LENGTHENER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LIMB LENGTHENER HSB ORTHOFIX INC T10-215-265

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other