BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 2192443 · Received July 8, 2011

    Report

    Report Number
    3008524126-2011-00018
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    PMA / PMN Number
    K010322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE TIBIAL ISKD LENGTHENER WAS PLACED IN THE FEMUR IN (B)(6) 2010. THE LENGTHENER DISTRACTED TOO FAST AND PATIENT SUFFERED FROM DELAYED UNION. X-RAYS TAKEN (B)(6) 2010 SHOWED A BROKEN DISTAL SCREW THAT WAS NOT REPLACED. PATIENT SUFFERED FROM ATROPHIC PSEUDARTHROSIS WITH A REST DEFECT DISTANCE OF 7MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LIMB LENGTHENER HSB ORTHOFIX INC. F12-300-380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other