BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3216770 · Received July 10, 2013

    Report

    Report Number
    0009617544-2013-00257
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    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; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; MATERIAL ANALYSIS. RESULTS: THE REPORTED EVENT OF A XIA 3 TITANIUM ROD BREAKAGE WAS CONFIRMED VIA A REVIEW OF THE PATIENT'S X-RAYS AND VISUAL INSPECTION. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND NO MANUFACTURING ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED. MATERIAL ANALYSIS WAS ALSO PERFORMED AND CONCLUDED THE XIA 3 TITANIUM ROD BROKE DUE TO FATIGUE. POSSIBLE FACTORS CONTRIBUTING TO POSSIBLE ROD BREAKAGE ARE: THE SKIPPING OF LEVELS BY THE SURGEON, TIME SINCE IMPLANTATION, THE WEIGHT AND ACTIVITY OF PATIENT, AND ANY FALLS OR HIGH LOAD COMPLICATIONS. PER THE IFU, THE IMPLANTS CANNOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE. IT 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 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 BREAKAGE. CONCLUSION: MATERIAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THE ROD BROKE DUE TO FATIGUE. THE 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 BREAKAGE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE CUSTOMER REPORTED EVENT OF A XIA 3 TITANIUM ROD BREAKAGE WAS CONFIRMED VIA A REVIEW OF THE PATIENT'S X-RAYS. HOWEVER, NO SAMPLE HAS BEEN RETURNED FOR FURTHER ANALYSIS. ADDITIONALLY, NO LOT INFORMATION HAS BEEN RECEIVED, SO NO REVIEW OF THE MANUFACTURING RECORD COULD BE PERFORMED. INFORMATION ON THIS CASE IS VERY LIMITED AND DUE TO THIS, NO DEFINITE CONCLUSIONS CAN BE MADE ABOUT THE CAUSE OF THE EVENT. PER THE IFU, THE IMPLANTS CANNOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE. IT 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. THIS MAY RESULT IN FURTHER SIDE EFFECTS OR NECESSITATE THE EARLY REMOVAL OF THE OSTEOSYNTHESIS DEVICE. CONCLUSION: POSSIBLE FACTORS CONTRIBUTING TO POSSIBLE 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. HOWEVER, WITHOUT ADDITIONAL INFORMATION, THIS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    FOUND BREAKAGE OF XIA3 ROD ABOUT ONE AND A HALF YEARS AFTER SURGERY. THE OBSERVATION IS PERFORMED NOW AND REVISION SURGERY IS NOT PLANNED.

    Description of Event or Problem · 1

    FOUND BREAKAGE OF XIA3 ROD ABOUT ONE AND A HALF YEARS AFTER SURGERY. THE OBSERVATION IS PERFORMED NOW AND REVISION SURGERY IS NOT PLANNED.

    Description of Event or Problem · 1

    FOUND BREAKAGE OF XIA3 ROD ABOUT ONE AND A HALF YEARS AFTER SURGERY. THE OBSERVATION IS PERFORMED NOW AND REVISION SURGERY IS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318773 UNKNOWN_SPINE_PRODUCT IMPLANT NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1