BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISKD ( INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

    MDR report key: 724550 · Received June 9, 2006

    Report

    Report Number
    2183449-2006-00009
    Event Type
    Other
    Date Received
    June 9, 2006
    Date of Event
    April 1, 2006
    Report Date
    June 8, 2006
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT RECEIVED ON 04/19/2006 ALLEGED THAT THE DEVICE EITHER MALFUNCTIONED OR WAS MISLABELED. ADDITIONAL INFORMATION FROM THE DISTRIBUTOR WAS REQUESTED IMMEDIATELY FOLLOWING RECEIPT OF THE INITIAL REPORT. COPIES OF THE PT'S X-RAY WERE NOT MADE AVAILABLE TO THE MANUFACTURER UNTIL 06/02/2006 WHICH ENABLED US TO REASSESS THE EVENT AND MAKE A REPORTABILITY DETERMINATION. FURTHER INVESTIGATION OF THIS EVENT WILL BE CONDUCTED AND ADDITIONAL INFORMATION FROM THE DISTRIBUTOR HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    AN ISKD LENGTHENER WAS IMPLANTED FOR DISTRACTION OF THE PT'S LIMB. NO PROBLEMS WERE REPORTED DURING LENGTHENING PROCESS, HOWEVER, THE LENGTHENER STOPPED DISTRACTING FURTHER WHEN THE PT REACHED 21.7MM. THE DISTRIBUTOR IS ALLEGING THAT THE IMPLANTED LENGTHENER IS A 50MM LENGTHENER THAT WAS LABELED AS A 80MM LENGTHENER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISKD ( INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) IMPLANTABLE LENGTHENER HSB ORTHOFIX INC. F14-300-380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR