BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM

    MDR report key: 3286502 · Received August 14, 2013

    Report

    Report Number
    0009617544-2013-00310
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K071373
    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: DEVICE HISTORY REVIEW, RISK ASSESSMENT. RESULTS: THE CUSTOMER EVENT OF A XIA 3 TITANIUM ROD FRACTURE WAS CONFIRMED VIA VISUAL INSPECTION OF THE RETURNED DEVICE. THE IFU STATES THAT THE IMPLANT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA, AND THAT THE DEVICE MAY NEED TO BE REPLACED IN THE FUTURE. IT ALSO STATES THAT THE STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE OR FRACTURE OR DEFORMATION OF THE IMPLANTS, BEFORE THE BONE GRAFT HAS BECOME COMPLETELY CONSOLIDATED. THE EXTENDED PERIOD OF TIME BETWEEN SURGERIES (~ 18 MONTHS) 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. CONCLUSION: THE ROOT CAUSE OF THE FAILURE IS LIKELY A FATIGUE FRACTURE DUE TO PROLONGED IMPLANTATION WITHIN THE BODY WITH A POSSIBLE LACK OF FUSION CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER THE PRIMARY SURGERY, THE ROD BREAKAGE WAS CONFIRMED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER THE PRIMARY SURGERY, THE ROD BREAKAGE WAS CONFIRMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390439 XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM IMPLANT MNH STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR