BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA ROD DIA 6 X 400

    MDR report key: 1893032 · Received October 28, 2010

    Report

    Report Number
    9617544-2010-00434
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 5, 2010
    Report Date
    October 9, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT GOT THE OPERATION BECAUSE OF SCOLIOSIS IN (B)(6), 2008. HE FOUND ONE SIDE ROD WAS BROKEN IN (B)(6), 2010 AND TWO SIDES RODS WERE BROKEN IN (B)(6), 2010. NOW THE DOCTOR WANTS TO DO THE REVISION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA ROD DIA 6 X 400 IMPLANT NKB STRYKER SPINE BORDEAUX NA PUF

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR