BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR ASSY ONE LEVEL PLATE SIZE 12

    MDR report key: 3960216 · Received July 28, 2014

    Report

    Report Number
    0009617544-2014-00331
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; RESULTS: MANUFACTURING FILES COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED AND NO PART WAS RETURNED FOR VISUAL EXAMINATION. THERE WAS NO DELAY IN SURGERY AND THE PLATE WAS SUCCESSFULLY INSTALLED USING A 14 MM HAND DRILL GUIDE. CONCLUSION: NO SPECIFIC DETAILS WERE PROVIDED CONCERNING THE TECHNIQUE USED, SUCH AS OVER-ARTICULATION OF THE DRILL GUIDE DURING INSTALLATION OR REMOVAL OF THE DRILL GUIDE. THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE IS MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A C3-4 ACDF PROCEDURE WAS PERFORMED. A 12MM AVIATOR PLATE WAS USED AND THE SURGEON HAND DRILLED USING THE 14MM DRILL/GUIDE. WHEN INSERTING THE RIGHT C3 SCREW (4.0 X 14 VST), THE SCREW HEAD BECAUSE CAUGHT THE LOCKING FLANGE. THE FLANGE WAS BURIED BELOW THE SCREW. SURGEON DECIDED TO LEAVE SCREW IN AS THE PURCHASE WAS VERY SOLID AND NOTHING WAS PROMINENT. ALL 3 SCREWS WERE LOCKED WITH SECONDARY LOCKING MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A C3-4 ACDF PROCEDURE WAS PERFORMED. A 12MM AVIATOR PLATE WAS USED AND THE SURGEON HAND DRILLED USING THE 14MM DRILL/GUIDE. WHEN INSERTING THE RIGHT C3 SCREW (4.0 X 14 VST), THE SCREW HEAD BECAUSE CAUGHT THE LOCKING FLANGE. THE FLANGE WAS BURIED BELOW THE SCREW. SURGEON DECIDED TO LEAVE SCREW IN AS THE PURCHASE WAS VERY SOLID AND NOTHING WAS PROMINENT. ALL 3 SCREWS WERE LOCKED WITH SECONDARY LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437792 AVIATOR ASSY ONE LEVEL PLATE SIZE 12 IMPLANT-AVIATOR PLATE KWQ STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR