BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 225355 · Received May 25, 1999

    Report

    Report Number
    2242816-1999-00040
    Event Type
    Malfunction
    Date Received
    May 25, 1999
    Report Date
    May 25, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RING SYSTEM WAS APPLIED TO A PILON FRACTURE, APPROXIMATELY 6 WEEKS LATER IT WAS NOTED ONE OF THE WIRE CARRIAGE BOLTS WAS BROKEN. THE BOLT WAS REPLACED WITHOUT INCIDENT. 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