BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM

    MDR report key: 4171446 · Received October 14, 2014

    Report

    Report Number
    3005525032-2014-00108
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    NKB
    PMA / PMN Number
    K113666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE INSPECTION REVEALED MULTIPLE DENTS ON THE EDGE OF THE SCREW HEAD, SUGGESTING THAT THE SCREW WAS IMPLANTED AT A HIGH ANGULATION. THE SIZE OF THE DENTS WAS INDICATIVE OF HIGH TORQUE APPLICATION. SINCE IT WAS CONFIRMED THAT FINAL TIGHTENING DID NOT EXCEED 12 NM, IT IS POSSIBLE THAT THIS HIGH TORQUE WAS APPLIED DURING PROVISIONAL TIGHTENING WITH THE UNIVERSAL TIGHTENER. THE PRESENCE OF MULTIPLE ON THE SCREW HEAD AND TEETH SHOW THAT MULTIPLE TIGHTENING ATTEMPTS WITH THE BLOCKER HAD BEEN PERFORMED ON THIS SCREW. CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE OVER-TIGHTENING OF THE BLOCKER AT A HIGH ANGULATION WITH MULTIPLE TIGHTENING ATTEMPTS LIKELY CONTRIBUTING TO THE EVENT. THESE CONDITIONS LIKELY LEAD TO DEFORMATION OF THE SCREW HEAD, WHICH ALLOWED IT TO PASS THROUGH THE TULIP WHEN THE FINAL TIGHTENING TORQUE WAS APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TIGHTENED THE BLOCKER ON THE SCREW AND IT KEPT GOING IN AND THE SURGEON NOTICED THAT IT WAS WELL BELOW WHERE THE OTHERS ALREADY IMPLANTED WERE SITTING ONCE FINAL TORUQED. THE SURGEON REMOVED THREE BLOCKERS ON ONE SIDE, TOOK OUT A ROD AND WENT TO TOGGLE THE HEAD ON THE LEFT S1 SCREW AND IT EASILY POPPED OFF. THE SURGEON REMOVED IT AND PUT IN A NEW SCREW, DROPPED IN THE ROD AND SET SCREWS AND FINISHED THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TIGHTENED THE BLOCKER ON THE SCREW AND IT KEPT GOING IN AND THE SURGEON NOTICED THAT IT WAS WELL BELOW WHERE THE OTHERS ALREADY IMPLANTED WERE SITTING ONCE FINAL TORUQED. THE SURGEON REMOVED THREE BLOCKERS ON ONE SIDE, TOOK OUT A ROD AND WENT TO TOGGLE THE HEAD ON THE LEFT S1 SCREW AND IT EASILY POPPED OFF. THE SURGEON REMOVED IT AND PUT IN A NEW SCREW, DROPPED IN THE ROD AND SET SCREWS AND FINISHED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650359 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM IMPLANT-SCREW NKB STRYKER SPINE-SWITZERLAND B22664

    Patients

    Seq Age Sex Outcome Treatment
    1