BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 224913 · Received May 19, 1999

    Report

    Report Number
    2242816-1999-00027
    Event Type
    Malfunction
    Date Received
    May 19, 1999
    Date of Event
    January 13, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED FOR A TIBIAL SHAFT FRACTURE. FOUR DAYS LATER IT WAS NOTED THAT ONE OF THE WIRE CARRIAGE BOLTS WAS BROKEN. THE BOLT WAS REPLACED. THERE WAS NO INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other