BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM

    MDR report key: 3323188 · Received September 3, 2013

    Report

    Report Number
    3005525032-2013-00087
    Event Type
    Injury
    Date Received
    September 3, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 6, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    NKB
    PMA / PMN Number
    K060979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE CUSTOMER REPORTED EVENT OF A XIA 3 VITANIUM ROD FRACTURE COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED. POSSIBLE FACTORS CONTRIBUTING TO ROD BREAKAGES ARE THE SKIPPING OF LEVELS BY THE SURGEON, THE AMOUNT OF TIME SINCE IMPLANTATION, THE WEIGHT AND ACTIVITY OF PATIENT, AND ANY FALLS OR HIGH LOAD COMPLICATIONS. THE YEAR PERIOD OF TIME BETWEEN SURGERY AND THE EVENT SUGGESTS THAT FUSION OF THE SPINE MAY NOT HAVE OCCURRED AND AS A RESULT THE CONSTRUCT WAS LEFT TO SUPPORT THE ENTIRE WEIGHT OF THE SPINE, WHICH MAY HAVE LED TO A POSSIBLE BREAKAGE. HOWEVER, NONE OF THE POSSIBLE FACTORS COULD BE CONFIRMED. CONCLUSION: THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED DUE TO THE ABSENCE OF THE DEVICE AND INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROD BROKE ONE YEAR AFTER XIA 3 SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROD BROKE ONE YEAR AFTER XIA 3 SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436700 XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM SPINAL ROD NKB STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R