BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 5.5. X 40 MM

    MDR report key: 1895521 · Received November 5, 2010

    Report

    Report Number
    9617544-2010-00442
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 15, 2009
    Report Date
    October 21, 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
    JA
    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

    ON (B)(6) 2009, THE PRIMARY PLIF SURGERY WAS PERFORMED AT L3-L5 FOR STENOSIS. ON (B)(4) 2010, THE EXTRACTION SURGERY (REMOVING ALL THE IMPLANTS) WAS PERFORMED SINCE THE BONE FUSION WAS OBTAINED. DURING THIS SURGERY, IT WAS FOUND THAT THE TIP OF THE SCREWS AT L5 (BOTH SIDES) WERE BROKEN ABOUT 5-10 MM. THE BROKEN TIPS COULD NOT BE REMOVED THUS THEY REMAIN IN THE BONE. THE SURGEON COMMENTED THAT HE EXPERIENCED THE EVENT OF THE SCREW FRACTURED AT THE TIP FOR THE FIRST TIME. THE PRODUCTS EXPLANTED WILL BE AVAILABLE FOR EVAL, HOWEVER NO X-RAY WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 5.5. X 40 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR