BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA3 TITANIUM ROD DIAM 6MM CP TI L 120MM

    MDR report key: 2925002 · Received January 17, 2013

    Report

    Report Number
    9617544-2013-90035
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    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 AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT THE SURGERY WITH THE XIA3. ON (B)(6) 2012, WHEN THE SURGEON CONFIRMED X-RAY, THE ROD WAS BROKEN. THEREFORE, THE SURGEON IS PLANNING REVISION SURGERY ON (B)(6) 2012. THE SALES REP OBTAINS DETAILED INFO AT THE TIME OF THE REVISION SURGERY ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25624 XIA3 TITANIUM ROD DIAM 6MM CP TI L 120MM IMPLANT NKB STRYKER SPINE BORDEAUX NA SS6

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R XIA 3 TITANIUM ROAD DIAM 6MM CP TI L, 48232100,| 100MM