BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480

    MDR report key: 1760380 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00270
    Event Type
    Injury
    Date Received
    July 9, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 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 (B)(6) PATIENT ((B)(6)) REC'D PRIMARY SURGERY (T2-L3, PEDICLE SCREWS AT L3 AND A HOOK AT L2 FOR ONE SIDE ONLY) USING XIA 4.5 FOR SCOLIOSIS. ON (B)(6), 2010, IT WAS FOUND, NO PROBLEM WITH THE IMPLANTS AT THE FOLLOW-UP CHECK. IN THE BEGINNING OF (B)(6), 2010 (EXACT DATE IS UNK): THE PT COMPLAINED OF PAIN. ON (B)(6), 2010, THE PT VISITED THE SURGEON AND IT WAS FOUND THAT THE ROD FRACTURED. THE SURGEON WAS PLANNING TO PERFORM THE REVISION SURGERY TO REPLACE THE FRACTURED ROD AND ELONGATE THE GROWING RODS, BUT IT WAS FOUND THAT THE ANESTHESIA WOULD NOT BE WORKING WELL, THUS THE REVISION SURGERY WAS POSTPONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention