BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 254568 · Received December 15, 1999

    Report

    Report Number
    2242816-1999-00065
    Event Type
    Injury
    Date Received
    December 15, 1999
    Date of Event
    November 1, 1999
    Report Date
    December 14, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED TO TREAT A DISTAL RADIUS FRACTURE ON 11/1/99. AT THE FIRST FOLLOW-UP VISIT, IT WAS NOTED THE FIXATOR WAS LOOSE. A SECOND SURGERY WAS PERFORMED TO REALIGN THE FRACTURE AND REAPPLY THE FIXATOR. AT THE NEXT FOLLOW-UP VISIT, IT WAS NOTED THE FIXATOR WAS LOOSE. A THIRD SURGERY WAS PERFORMED TO REALIGN THE FRACTURE AND REPLACE THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. 04003 127231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention