BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE - 22MM

    MDR report key: 1881333 · Received October 7, 2010

    Report

    Report Number
    1530901-2010-00123
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    January 9, 2009
    Report Date
    October 7, 2010
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. NO DEVICE WAS AVAILABLE FOR EVALUATION; THE FAILURE OF THE LOCKING ARM IS ADDRESSED IN THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA) OF THE DEVICE DESIGN DOSSIER. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FURTHER 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 USING THE MANTA RAY ANTERIOR CERVICAL PLATE, THE INFERIOR FIXED SCREWS ON THE PLATE BOTH PINNED THE RETAINING LOCKING ARM. THE SURGEON REMOVED THE SCREWS AND REPLACED THEM WITH RESCUE SCREWS INSTEAD OF THE SPARES IN THE CADDY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. THE COMPLAINT SCREWS WERE DISCARDED IN THE OPERATION ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE - 22MM MANTARAY KWQ THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1