BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 4866915 · Received June 24, 2015

    Report

    Report Number
    0009617544-2015-00293
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K050461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE RETURNED BLOCKER WAS EXAMINED AND EXHIBITED INDENTATIONS, WHICH SUGGESTED THAT FINAL TIGHTENING HAD BEEN PERFORMED. REVIEW OF THE X-RAYS CONFIRMS THAT THE SPINE WAS FIXED FROM L4-L5 AND THAT THE BLOCKER REMAINED THREADED WITHIN THE SCREW TULIP. THE SCREW REMAINS IMPLANTED AND IS UNAVAILABLE FOR EVALUATION, AND THE POSITION OF THE ROD CANNOT BE DETERMINED IN THE X-RAYS GIVEN. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING MANUFACTURING RECORD REVIEW. CONCLUSION: DUE TO THE MULTIFACTORIAL NATURE, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR FUSION UTILIZING STRYKER SPINE IMPLANTS ON (B)(6) 2015. ON (B)(6) 2015 THAT SAME PATIENT WAS FORCED TO HAVE A REVISION SURGERY DUE TO OUR RODS COMING OUT OF THE SCREWS, THUS PROVIDING NO STABILITY TO ALLOW THE FUSION TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR FUSION UTILIZING STRYKER SPINE IMPLANTS ON (B)(6) 2015. ON (B)(6) 2015 THAT SAME PATIENT WAS FORCED TO HAVE A REVISION SURGERY DUE TO OUR RODS COMING OUT OF THE SCREWS, THUS PROVIDING NO STABILITY TO ALLOW THE FUSION TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408572 XIA TITANIUM 4.5 BLOCKER PEDICLE SCREW SPINAL SYSTEM NKB STRYKER SPINE-FRANCE KWM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R