BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 217591 · Received April 1, 1999

    Report

    Report Number
    2242546-1999-00016
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    February 1, 1999
    Report Date
    March 31, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FULL 180MM RING WAS APPLIED TO A MALE PT OF AVERAGE HEIGHT AND WEIGHT TO TREAT A PROXIMAL TIBIA FRACTURE. APROX 3 WEEKS LATER, IT WAS NOTED THAT ONE OF THE WIRE CARRIAGES AND TWO OF THE SCREW CARRIAGES WERE BROKEN. THERE WAS NO INJURY TO THE PT; HOWEVER, THE PT WAS BROUGHT TO THE OPERATING ROOM TO HAVE THE SYSTEM REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 13070/13080 037469/050503/038544

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other