BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA-21 SYSTEM

    MDR report key: 495362 · Received November 10, 2003

    Report

    Report Number
    2242816-2003-00018
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    January 18, 2002
    Report Date
    November 7, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OMEGA-21 SYSTEM WAS ORIGINALLY IMPLANTED IN 2001. APPROXIMATELY ONE YEAR LATER THE SYSTEM WAS REMOVED AS A RESULT OF THE PATIENTS COMPLAINTS OF "PAIN". DURING THE REMOVAL PROCEDURE IT WAS NOTED ONE OF THE SCREWS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA-21 SYSTEM SPINAL FIXATION JDN EBI, L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other