BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 5.5 X 35MM

    MDR report key: 1840881 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00305
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 12, 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
    BR
    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

    (B)(6), CLAIM ON BEHALF OF HOSPITAL (B)(6) - (B)(6). MEDICAL REPORT: DURING THE SURGERY, IT WAS VERIFIED THAT THE SCREW ((B)(4) - XIA II SCREW POLIAXIA L 5,5 X 35MM - LOT: 068587) WERE BROKEN IN THE HALF OF ITS EXTENSION. THE SAME WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 5.5 X 35MM IMPLANT NKB STRYKER SPINE BORDEAUX NA 068587

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK