BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 224423 · Received May 18, 1999

    Report

    Report Number
    2242816-1999-00025
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROX 1 WEEK AFTER THE FIXATOR WAS APPLIED THE MD NOTED ONE OF THE LOCKING CONNECTORS WAS LOOSE. THE FIXATOR WAS REPLACED WITHOUT A SECOND SURGERY. 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. 01001 030274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other