BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR PYRAMID PLATE

    MDR report key: 3913158 · Received June 27, 2014

    Report

    Report Number
    MW5037018
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, I UNDERWENT ANTERIOR LUMBAR DISCECTOMY AND FUSION SURGERY IN WHICH THE SURGEON INSTALLED A MEDTRONIC PYRAMID ANTERIOR PLATE. THREE WEEKS POST OP X-RAYS REVEALED THAT THE TOP SCREW BACKED OUT AND WAS PROXIMATE TO MAJOR BLOOD VESSELS. THE PLATE HAS LOCKING HARDWARE TO KEEP THE SCREWS FROM BACKING OUT SO THIS SHOULD NOT HAVE HAPPENED. I UNDERWENT A SECOND SURGERY ON (B)(6) 2014, WHICH INCLUDED REMOVAL OF THE PYRAMID PLATE AND A POSTERIOR HARDWARE INSTALLATION SURGERY TO SECURE THE INITIAL FUSION. AFTER THE SECOND SURGERY THE SURGEON ADVISED ME THAT ALL OF THE SCREWS WERE LOOSE EVEN THOUGH THEY WERE SUPPOSED TO BE LOCKED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376046 ANTERIOR PYRAMID PLATE NONE KWQ MEDTRONIC 35

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R