BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI OPTIROM FIXATOR

    MDR report key: 696131 · Received March 24, 2006

    Report

    Report Number
    MW1038344
    Event Type
    Injury
    Date Received
    March 24, 2006
    Date of Event
    November 12, 2004
    Report Date
    March 17, 2006
    Manufacturer
    EBI (A BIOMED CO)
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THERE IS CURRENTLY A HEATED DEBATE IN THE ORTHOPEDIC COMMUNITY ON WHETHER IT IS BEST TO USE SOFT TISSUE SLEEVES THAT EBI AND OTHER FIXATOR MFRS PROMOTE OR USE 2" TO 3" INCISIONS AND RETRACTORS TO BE 100% CERTAIN THE NERVES ARE OUT OF THE WAY OF THE BONE DRILL. I AM LIVING PROOF THAT SOFT TISSUE SLEEVES DO NOT WORK. THE FDA NEEDS TO STEP IN AND BAN THE USE OF SLEEVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI OPTIROM FIXATOR EXTERNAL EBLOW HTY EBI (A BIOMED CO) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S