BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 2935725 · Received January 3, 2013

    Report

    Report Number
    3008524126-2012-00032
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    June 1, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE LENGTHENER WAS IMPLANTED (B)(6) 2012 AND STOPPED DISTRACTING. ON (B)(6) 2012, THE IMPLANT WAS REMOVED AND ANOTHER ISKD WAS IMPLANTED TO ACHIEVE LENGTH. INFORMATION SUGGESTS THAT THE 2ND LENGTHENER STOPPED DISTRACTING. THE 2ND IMPLANT REMAINED IMPLANTED UNTIL CONSOLIDATION AND WAS REMOVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3780 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LIMB LENGHTENER HSB ORTHOFIX INC. F12-300-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other