BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    MDR report key: 1760632 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00271
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 7, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER PLACING 2ND SCREW, THE SURGEON WANTED TO RE-ANPULATE. THE SCREW WAS ALREADY UNDER THE SPINAL BAR AND THE RESCUE DRIVER (DRIVER W/HALF MOON TO PUSH BACK SPRING BAR) WAS USED TO REMOVE THE SCREW WITH EASE. RESCUE SCREW WAS PLACED IN THE REANPULATION. AFTER ALL 4 SCREWS WERE PLACED, THE 2 CAMS WERE ROTATED 180 DEG FOR FINAL TIGHTENING. FINAL X-RAY LOOKED GREAT & SURGEON WAS HAPPY. UNSURE WHICH SCREW BACKED OUT. I COVERED THE CASE FOR ANOTHER REP WHO WILL CONTINUE TO MONITOR THE SITUATION SHOULD A REVISION ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR ASSY TWO LEVEL PLATE SIZE 28 IMPLANT KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK