BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 228373 · Received June 17, 1999

    Report

    Report Number
    2242816-1999-00048
    Event Type
    Malfunction
    Date Received
    June 17, 1999
    Date of Event
    June 1, 1999
    Report Date
    June 17, 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 PROXIMAL TIBIA FRACTURE. APPROX 4 WEEKS LATER IT WAS NOTED A WIRE CARRIAGE WAS BROKEN. THE WIRE CARRIAGE WAS REPLACED IN THE MD'S OFFICE. 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. 13070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other