BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 1344749 · Received January 21, 2009

    Report

    Report Number
    2242816-2008-00161
    Event Type
    Malfunction
    Date Received
    January 21, 2009
    Date of Event
    December 17, 2008
    Report Date
    December 23, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED A BROKEN SCREW AT L3. PT OUTCOME: THERE WAS NO ADVERSE EVENT TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM MNI EBI, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1