BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP MONOAXIAL SCREW 7.5 X 50MM

    MDR report key: 2092949 · Received April 20, 2011

    Report

    Report Number
    9617544-2011-00143
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, "REMOVAL OF SCREW IN LEFT S1 7.5 X 50 MONOAXIAL XIA 11 SCREW BROKE INSIDE PEDICLE. USED A UNIVERSAL REMOVAL SET TO CORE AROUND SCREW AND REVERSE THREAD OUT OF PEDICLE. REINSTRUMENTED WITH LARGE SCREW AND EXTENDED FUSION TO L3."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP MONOAXIAL SCREW 7.5 X 50MM IMPLANT NKB STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK