BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP MONOAXIAL SCREW 6.5 X 45MM

    MDR report key: 4093296 · Received September 16, 2014

    Report

    Report Number
    3005525032-2014-00098
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    January 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K060361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW. RESULTS: THE DEVICE WAS NOT RECEIVED FOR EVALUATION, TESTING AND INSPECTION COULD NOT BE PERFORMED TO AID IN ROOT CAUSE ANALYSIS. HOWEVER, IT WAS CONFIRMED THAT THE DEVICE WAS IMPLANTED FOR ABOUT 11 MONTHS PRIOR TO THE FRACTURE BEING NOTICED. FURTHERMORE, THE BREAKAGE OCCURRED AT S1, WHICH IS AN AREA THAT POSSESSES A HIGH LORDOSIS. THIS CAN CAUSE A HIGH DEGREE OF FORCE TO BE GENERATED ON THE SCREWS IMPLANTED IN THIS REGION. IT IS UNKNOWN WHETHER FUSION HAD OCCURRED, BUT IF IT HAD NOT, THEN THE CONSTRUCT WOULD BE TASKED WITH BEARING THE LOAD OF THE SPINE. THIS ALONG WITH THE EXTENDED IMPLANTATION MAY HAVE LED TO AN EVENTUAL FATIGUE BREAKAGE OF THE DEVICE. CONCLUSION: HOWEVER, BECAUSE NO DEVICE WAS RECEIVED FOR EVALUATION, THIS CANNOT BE DETERMINED CONCLUSIVELY. DUE TO THE MULTIFACTORIAL NATURE OF THE EVENT AND INABILITY TO TEST THE DEVICE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OF 5TH LUMBAR WAIST CRACKED AND HAVE VERTEBRAL SLIPPAGE DISEASE. THE SURGEON PERFORMED INTERVERTEBRAL FUSION SURGERY TO PATIENT; AFTER FOUR MONTHS THE PATIENT FELT THE PAIN IN THE WAIST. THE X-RAY SHOWED THE SCREW HAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OF 5TH LUMBAR WAIST CRACKED AND HAVE VERTEBRAL SLIPPAGE DISEASE. THE SURGEON PERFORMED INTERVERTEBRAL FUSION SURGERY TO PATIENT; AFTER FOUR MONTHS THE PATIENT FELT THE PAIN IN THE WAIST. THE X-RAY SHOWED THE SCREW HAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571634 XIA LP MONOAXIAL SCREW 6.5 X 45MM IMPLANT-SCREW KWP STRYKER SPINE-SWITZERLAND B26794

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR