BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR ASSY TWO LEVEL PLATE SIZE 34

    MDR report key: 3924843 · Received July 10, 2014

    Report

    Report Number
    0009617544-2014-00301
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO DEVICE RETURNED;RESULTS: MANUFACTURING FILES COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED AND NO PART WAS RETURNED FOR VISUAL EXAMINATION. NO SPECIFIC DETAILS WERE PROVIDED CONCERNING THE TECHNIQUE USED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT (SUCH AS OVER-ARTICULATION OF THE DRILL GUIDE/TAP/SCREW). CONCLUSION: THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE IS MULTIFACTORIAL IN NATURE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED; RESULTS: NO SPECIFIC DETAILS WERE PROVIDED CONCERNING THE TECHNIQUE USED, THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT (SUCH AS OVER-ARTICULATION OF THE DRILL GUIDE/TAP/SCREW). THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE IS MULTIFACTORIAL IN NATURE. CONCLUSION: THE REPORTED DEVICE WAS CONFIRMED BY THE STRYKER REP TO BE AN AVIATOR ASSY TWO LEVEL PLATE. MANUFACTURING FILES COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED AND NO PART WAS RETURNED FOR VISUAL EXAMINATION. A 10 MINUTE DELAY IN SURGERY RESULTED AND THE PLATE WAS SUCCESSFULLY INSTALLED. THERE WERE NO NEW HAZARD/HARMS IDENTIFIED OR BREACH OF SEVERITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LOCKING WINGS ON THE AVIATOR CERVICAL PLATE POPPED UP LATERALLY AFTER SCREW INSERTION WITH A SELF - DRILLING 4.0 X 14 SCREW. THE SURGEON WAS ABLE TO USE A PENFIELD FOUR AND A MALLET AND KNOCK IT BACK INTO PLACE AND DID NOT TO REPLACE THE PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LOCKING WINGS ON THE AVIATOR CERVICAL PLATE POPPED UP LATERALLY AFTER SCREW INSERTION WITH A SELF - DRILLING 4.0 X 14 SCREW. THE SURGEON WAS ABLE TO USE A PENFIELD FOUR AND A MALLET AND KNOCK IT BACK INTO PLACE AND DID NOT TO REPLACE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403778 AVIATOR ASSY TWO LEVEL PLATE SIZE 34 IMPLANT-CERVICAL PLATE KWQ STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1