BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 1944790 · Received December 10, 2010

    Report

    Report Number
    3008524126-2010-00003
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 6, 2010
    Report Date
    December 10, 2010
    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

    INFO PROVIDED STATES THAT THE ISKD LENGTHENER DISTRACTED TOO QUICKLY DURING TREATMENT. A CAST WAS PLACED ON THE PT. LENGTHENER WAS REMOVED AND REPLACED WITH ANOTHER LENGTHENER. PT DISTRACTED TO FULL LENGTH AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LENGTHENER HSB ORTHOFIX INC T10-255-305

    Patients

    Seq Age Sex Outcome Treatment
    1