BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 45MM

    MDR report key: 1895522 · Received November 5, 2010

    Report

    Report Number
    9617544-2010-00444
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT HAD ADJACENT LEVEL DISEASE, NOT RELATED TO BROKEN SCREW, AND WAS BROUGHT BACK TO FUSE THE LEVEL ABOVE PRIOR FUSION. UPPER PORTION OF BROKEN SCREW WAS REMOVED AND LOWER PORTION WAS LEFT IN (L4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 6.5 X 45MM IMPLANT NKB STRYKER SPINE BORDEAUX NA A83131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK