BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 64927 · Received January 23, 1997

    Report

    Report Number
    2242816-1997-00004
    Event Type
    Injury
    Date Received
    January 23, 1997
    Date of Event
    January 2, 1997
    Report Date
    January 22, 1997
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 12/16/96, THE PT FELL, DISPLACING HER FACTURE. THE PT WAS TAKEN TO THE OR AND THE FRACTURE WAS RE-REDUCED AND THE ORIGINAL DFS REAPPLIED. ON 1/2/97 PT HAD OPEN DISPLACEMENT OF HER FRACTURE UPON WEIGHTBEARING A NEW DFS TO REPLACE HER ORIGINAL DFS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY ELECTRO-BIOLOGY, INC. 01001 011882

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention