BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 250584 · Received November 12, 1999

    Report

    Report Number
    2242816-1999-00062
    Event Type
    Malfunction
    Date Received
    November 12, 1999
    Date of Event
    October 28, 1999
    Report Date
    November 11, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS BEING APPLIED TO A SEVEN YEAR-OLD MALE PT FOR A FEMUR FRACTURE. ONE OF THE BONE SCREWS WHILE BEING INSERTED INTO THE SECOND CORTEX. THE SCREW BROKE AT THE PROXIMAL CORTEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. A45-12040 113633

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other