BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA-21 SYSTEM

    MDR report key: 492143 · Received October 22, 2003

    Report

    Report Number
    2242816-2003-00012
    Event Type
    Malfunction
    Date Received
    October 22, 2003
    Report Date
    October 22, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PREVIOUSLY SCHEDULED PROCEDURE TO REMOVE THE HARDWARE, SEVERAL OF THE EXPANDABLE SCREWS SHEARED OFF AT THE BONE SURFACE. AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE PIECES, THE SURGEON DECIDED IT WOULD DO NO HARM TO THE PT TO LEAVE THE SCREW FRAGMENTS IN.

    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 UNKNOWN Other