BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE 2 LEVEL, 40MM

    MDR report key: 2505119 · Received March 21, 2012

    Report

    Report Number
    3008657535-2012-00025
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    November 2, 2011
    Report Date
    March 21, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS OF ALL DEVICE LOTS SHOWED NO ANOMALY. THE COMPLAINT SAMPLE PART WILL NOT BE RETURNED SO AN EXACT DEVICE HISTORY REVIEW IS NOT POSSIBLE. INTEGRA'S INVESTIGATION DETERMINED THAT X-RAYS DO NOT CLEARLY SHOW IF THE SCREWS ARE, OR WERE, LOCKED PROPERLY TO BEGIN WITH. THERE IS NO INDICATION OF BROKEN RETAINING ARMS ON THE PLATE ON THE X-RAY. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT HAD A MANTA RAY ANTERIOR CERVICAL PLATE IMPLANTED. POST OPERATIVE RADIOGRAPHS TAKEN 6 WEEKS AFTER SURGERY SHOWED THAT A SELF TAPPING, VARIABLE SCREW HAS STARTED TO BACK OUT. DURING THE SURGICAL PROCEDURE, THE VARIABLE DRILL GUIDE WAS USED, THE GUIDE WAS FULLY SEATED AND THE SCREW WAS NOT OVERANGULATED. INTRAOPERATIVELY, SCREWS WERE CONFIRMED TO BE SEATED, AND THE RETAINING ARM WAS OVER THE HEAD OF THE SCREW. THE PT HAS NOT BEEN BROUGHT BACK FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE 2 LEVEL, 40MM MANTA RAY KWQ THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR