BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR

    MDR report key: 4925785 · Received July 16, 2015

    Report

    Report Number
    3008524126-2015-00016
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 15, 2015
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN THE U.S.

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED PT HAD ISKD DEVICE IMPLANTED FOUR YEARS AGO, IN (B)(6) 2015 THE PT SUFFERED TRAUMA DUE TO REFRIGERATOR FALLING ON THE PT'S LEG AND BREAKING THE ISKD IMPLANT. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463786 INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ISKD LIMB LENGTHENER HSB ORTHOFIX INC. F12-345-395

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention