BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR ASSY FOUR LEVEL PLATE SIZE 68

    MDR report key: 4171447 · Received October 14, 2014

    Report

    Report Number
    0009617544-2014-00438
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; VISUAL INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; LABELING REVIEW; ADDITIONAL DOCUMENT REVIEW. RESULTS: MANUFACTURING FILES WERE REVIEWED AND NO INCIDENTS WERE FOUND. TWO LOCKING BARS WERE CONFIRMED TO BE FRACTURED AND TWO WERE BENT. SOME OF THIS COULD BE A RESULT OF EXPLANTATION. ONE BLOCKER LACKED WITNESS MARKS IN THE SQUARE HOLE THAT WOULD INDICATE THAT IT WAS NOT LOCKED, HOWEVER, IT IS IN THE MIDDLE OF THE PLATE AND THE EVENT REPORTED THAT THE BOTTOM TWO LEVELS HAD THE SCREWS BACKING OUT. CONCLUSION: THE ROOT CAUSE IS NOT DETERMINED AND LIKELY MULIT-FACTORAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD OBSERVED SCREWS BACKING OUT OF AN AVIATOR PLATE ON X-RAY. THEREFORE THE SURGEON REMOVED THE PLATE. THE SURGEON OBSERVED THAT SOME OF THE GOLD BLOCKERS MAY OR MAY NOT HAVE BEEN IN THE LOCK POSITION BEFORE THE SURGEON BEGAN EXPLANTING. THE SPRING BAR LOCKING MECHANISMS ON THE BOTTOM TWO LEVELS OF THE PLATE DEFORMED AND/OR BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD OBSERVED SCREWS BACKING OUT OF AN AVIATOR PLATE ON X-RAY. THEREFORE THE SURGEON REMOVED THE PLATE. THE SURGEON OBSERVED THAT SOME OF THE GOLD BLOCKERS MAY OR MAY NOT HAVE BEEN IN THE LOCK POSITION BEFORE THE SURGEON BEGAN EXPLANTING. THE SPRING BAR LOCKING MECHANISMS ON THE BOTTOM TWO LEVELS OF THE PLATE DEFORMED AND/OR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650692 AVIATOR ASSY FOUR LEVEL PLATE SIZE 68 IMPLANT-PLATE KWQ STRYKER SPINE-FRANCE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1