BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM

    MDR report key: 3970204 · Received July 31, 2014

    Report

    Report Number
    3005525032-2014-00083
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K113666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: IT WAS OBSERVED THAT THE BLOCKER HAD DAMAGE ON THE TULIP THREADS. THIS SUGGESTS THAT THE BLOCKER WAS EITHER NOT SEATED PROPERLY DURING INSERTION OR THAT THE BLOCKER HAD JUMPED THREADS OR CROSS THREADED DURING FINAL TIGHTENING. THIS CAN OCCUR IF EXCESS TORQUE IS APPLIED DURING FINAL TIGHTENING OR IF CANTILEVER FORCE IS APPLIED. IT WAS STATED THAT THE SURGEON DID NOT USE THE ANTI-TORQUE KEY DURING TIGHTENING, WHICH PROVIDES COUNTER-TORQUE AND ALLOWS THE TORQUE WRENCH TO BE ALIGNED PROPERLY. IMPROPER INSERTION MAY HAVE INITIALLY CAUSED THE TULIP TO SLIGHTLY SPLAY, WHICH POSSIBLY LEAD TO DIFFICULTY DURING THE SUBSEQUENT TIGHTENING ATTEMPTS, AS THIS CONDITION READILY ALLOWS FOR THREAD MISALIGNMENT WHEN TORQUE IS APPLIED. THIS WOULD ALLOW THE BLOCKER TO CONTINUE TO SPIN AND EVENTUALLY JUMP THREADS, WHICH WAS OBSERVED DURING FUNCTIONAL TESTING. CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS IMPROPER INITIAL INSERTION BY THE USER CAUSING TULIP SPLAY AND MISALIGNING OF THE THREADS.

    Description of Event or Problem · 1

    IT¿S REPORTED THAT DURING XIA3 SURGERY, THE SURGEON INSERTED SCREW IN L3/L5. THE SURGEON PERFORMED THE FINAL TIGHTENING THE BLOCKER BY TORQUE WRENCH. HOWEVER THE BLOCKER CONTINUED TO TURN FREELY. THE RESULT WAS THE SAME ALTHOUGH THE SURGEON CHANGED THE BLOCKER SEVERAL TIMES. THEREFORE THE SURGEON REMOVED THE SCREW. THE SURGEON CHANGED THE SCREW TO BRAND-NEW PRODUCT.

    Description of Event or Problem · 1

    IT铠REPORTED THAT DURING XIA3 SURGERY, THE SURGEON INSERTED SCREW IN L3/L5. THE SURGEON PERFORMED THE FINAL TIGHTENING THE BLOCKER BY TORQUE WRENCH. HOWEVER THE BLOCKER CONTINUED TO TURN FREELY. THE RESULT WAS THE SAME ALTHOUGH THE SURGEON CHANGED THE BLOCKER SEVERAL TIMES. THEREFORE THE SURGEON REMOVED THE SCREW. THE SURGEON CHANGED THE SCREW TO BRAND-NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448390 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM IMPLANT-SCREW MNH STRYKER SPINE-SWITZERLAND B40308

    Patients

    Seq Age Sex Outcome Treatment
    1