BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL LUMBAR IMPLANTS

    MDR report key: 1381607 · Received March 16, 2009

    Report

    Report Number
    2242816-2009-00009
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 20, 2009
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MARKINGS ARE OFF AND SCREWS END UP GOING IN CROOKED. THE SCREWS WERE NOT USED. PT OUTCOME: NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL LUMBAR IMPLANTS KWQ EBI, L.P. 525250

    Patients

    Seq Age Sex Outcome Treatment
    1