BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480

    MDR report key: 1841062 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00329
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 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) 2008, THE PRIMARY SURGERY (WITHOUT FUSION METHOD) WAS PERFORMED USING XIA4.5. THE SURGEON WAS PLANNING TO PERFORM ANOTHER SURGERY TO REPLACE THE RODS SOON SINCE THE EXTENDED CONNECTOR WAS FULLY EXTENDED BUT BEFORE THAT SURGERY, IT WAS FOUND (WHEN FOUND IS UNK) THAT ONE SIDE OF THE ROD FRACTURED (WHEN FRACTURED IS UNK) UNDERNEATH THE EXTENDED CONNECTOR. ON (B)(6), 2010, THE PT WILL BE REVISED TO REPLACE THE RODS. THE LOT NUMBER OF THE BROKEN ROD IS UNK, BUT IT IS EITHER GVU OR HFZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480 IMPALNT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR