BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 224807 · Received May 19, 1999

    Report

    Report Number
    2242816-1999-00032
    Event Type
    Malfunction
    Date Received
    May 19, 1999
    Date of Event
    May 14, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A HYBRID SYSTEM WITH 4 WIRE CARRIAGE AND BONE SCREWS WAS APPLIED TO A PROXIMAL TIBIA. ONE WEEK LATER THE PATIENT WAS TAKEN BACK TO THE OR TO WASH OUT THE INFECTION. WHILE MOVING THE PATIENT TO THE OR TABLE, THE WIRE CARRIAGE BROKE. THERE WAS NO INJURY TO THE PATIENT. THE ENTIRE CARRIAGE WAS REPLACED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. UNK 044133

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other