BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE - 43 MM

    MDR report key: 1854586 · Received September 9, 2010

    Report

    Report Number
    1530901-2010-00077
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 15, 2008
    Report Date
    September 9, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF INTEGRA'S TWO YEAR RETROSPECTIVE REVIEW, WHICH IS STILL ONGOING; INTEGRA CONCLUDED THAT THIS MEDICAL DEVICE REPORT SHOULD HAVE BEEN SUBMITTED AT THE TIME THAT THE COMPLAINT WAS RECEIVED. A REVIEW OF THE COMPLAINT MANAGEMENT SYSTEM SHOWED THAT THIS COMPLAINT WAS THE SECOND REPORTED INCIDENT OF THIS TYPE. THE DESIGN OF THE DEVICE WAS CHANGED IN 2008 TO ADDRESS THE REPORTED ISSUE. THE COMPLAINT SAMPLE WAS RECEIVED FOR EVAL. THE PLATE SHOWED SOME LIGHT SCRATCHES, THE SCREW HAD THE ANODIZING SCRAPED OFF THE HEAD OF THE SCREW. 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 SURGEON HAD INSERTED THE FOUR CORNER SCREWS TO SECURE THE MANTA RAY ANTERIOR CERVICAL PLATE, AND WHILE INSERTING THE FIFTH SCREW (A 4.0 X 16 MM VAR SELF DRILLING SCREW PART NUMBER 22-12-4016) INTO ONE OF THE CENTER HOLES OF THE PLATE, THE SCREW PULLED THROUGH THE PLATE. THE SURGERY WAS COMPLETED; THE AVAILABLE SPARE PLATE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE - 43 MM MANTARAY KWQ THEKEN SPINE W7797

    Patients

    Seq Age Sex Outcome Treatment
    1