BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 225002 · Received May 21, 1999

    Report

    Report Number
    2242816-1999-00037
    Event Type
    Malfunction
    Date Received
    May 21, 1999
    Date of Event
    May 18, 1999
    Report Date
    May 21, 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 CARRIAGES AND BONE SCREWS WAS APPLIED TO A PROXIMAL TIBIA. ELEVEN DAYS LATER, WHILE THE PATIENT WAS IN HIS HOSPITAL ROOM, IT WAS NOTED ONE OF THE WIRE CARRIAGES WAS BROKEN. THERE WAS NO INJURY TO THE PATIENT. THE ENTIRE CARRIAGE WAS REPLACED IN THE PATIENT'S ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. UNK 026977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other