BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3183045 · Received June 21, 2013

    Report

    Report Number
    0009617544-2013-00233
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K071373
    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 CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: NO PRODUCT HAS BEEN RETURNED, SO NO DEVICE INSPECTION COULD BE PERFORMED. DEVICE HISTORY REVIEW: ALL IMPLANT DEVICES IN BOTH OF THE POTENTIAL LOTS WERE MANUFACTURED TO SPECIFICATION. CONCLUSION: THE CUSTOMER REPORTED EVENT OF ROD BREAKAGE WAS CONFIRMED VIA THE PROVIDED X-RAYS WHICH SHOWED A CLEAR ROD BREAKAGE. THE ADVERSE CONSEQUENCE OF THIS FAILURE WAS A REVISION SURGERY IN WHICH THE CONSTRUCT WAS REINFORCED. 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. PROPER CHOICE OF IMPLANT IS ALSO CRUCIAL TO SUCCESS OF THE SURGERY. BASED ON THE X-RAY IMAGING, THE SPACER WAS NOT PROPERLY ALIGNED WITH THE SPINE AND THE REST OF THE CONSTRUCT WHICH WOULD CREATE HIGH STRESS AT THAT LEVEL. ALSO, THE PATIENT DOES NOT APPEAR TO HAVE PROPER SAGITTAL BALANCE, ANOTHER SOURCE OF HIGH STRESS. IT IS LIKELY THAT THE COMBINATION OF THESE HIGH STRESS SITUATIONS CAUSED THE IMPLANT TO FAIL AT THE LOCATION OF THE SPACER. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ON (B)(6) 2012 XIA3 PRIMARY SURGERY THAT FIXED TH4 / ILIAC WAS PERFORMED. THEN THE ROD BREAKAGE WAS CONFIRMED BY X-RAYS ON (B)(6) 2013. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 AND CONSTRUCT WAS REINFORCED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ON (B)(6) 2012, XIA3 PRIMARY SURGERY THAT FIXED TH4 / ILIAC WAS PERFORMED. THEN THE ROD BREAKAGE WAS CONFIRMED BY X-RAYS ON (B)(6) 2013. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 AND CONSTRUCT WAS REINFORCED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283462 XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM IMPLANT MNH STRYKER SPINE-FRANCE 557 OR 7MR

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R