BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 1840886 · Received September 10, 2010

    Report

    Report Number
    9617544-2010-00361
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 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
    MS, 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 "L4-S1 REVISION SURGERY FOR PSEUDO ORTHROSIS - BLOCKER LOOSE - LEFT SIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA WEE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR