BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STOP

    MDR report key: 2212456 · Received August 1, 2011

    Report

    Report Number
    2212456
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: FAILED L2-L3 SECOND-THIRD LUMBAR VERTEBRAE X-STOP.PROCEDURE: REVISION L2-L3 PLACEMENT OF AN X-STOP SPINOUS PROCESS BLOCKER.PATIENT WAS SEEN BACK IN CLINIC FOR POSTOPERATIVE EXAMINATION AND AT THAT TIME, RADIOGRAPHS WERE OBTAINED AND IT WAS NOTED THAT THE PATIENT'S HARDWARE HAD FAILED AND THAT THE X-STOP WAS NO LONGER CONNECTED. IT WAS DECIDED AT THAT POINT THAT URGENT REVISION WAS REQUIRED AND THE PATIENT WAS BOOKED FOR THE OR FOR THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP TITANIUM IMPLANT SPACER NQO MEDTRONIC SPINE LLC 12 MM 2232411

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR