BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE - 40MM

    MDR report key: 1853840 · Received September 9, 2010

    Report

    Report Number
    1530901-2010-00076
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 11, 2008
    Report Date
    September 9, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF INTEGRA'S TWO YEAR RETROSPECTIVE REVIEW, WHICH IS STILL ONGOING; WE HAVE CONCLUDED THAT THIS COMPLAINT SHOULD HAVE BEEN SUBMITTED AS AN MDR AT THE TIME OF THE COMPLAINT. THE COMPLAINT SAMPLE WAS RECEIVED FOR EVAL. IT WAS OBSERVED THAT THE BOTTOM OF THE SCREW HOLE WAS DEFORMED. A REVIEW OF THE COMPLAINT LOG SHOWED THAT THIS WAS THE FIRST RECORDED INCIDENT OF THIS KIND. THE DESIGN OF THE DEVICE WAS REVISED IN 2008. 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 DURING A SPINAL SURGERY PROCEDURE, THE MANTA RAY ANTERIOR CERVICAL PLATE WAS SECURED WITH THREE SCREWS THAT WERE IMPLANTED BUT NOT TIGHTENED. ON INSERTIN OF THE FOURTH SCREW THE PLATE MOVED SLIGHTLY, AND THE SCREW THAT WAS BEING INSERTED AND TIGHTENED WENT THROUGH THE PLATE. AS POSTERIOR CERVICAL SPINAL FIXATION HAD ALREADY BEEN COMPLETED, IT WAS DECIDED TO REMOVE THE MANTA RAY PLATE, AND THE SURGERY WAS COMPLETED WITHOUT USING THE SPARE DEVICE THAT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE - 40MM MANTARAY KWQ THEKEN SPINE W7202

    Patients

    Seq Age Sex Outcome Treatment
    1