BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 50MM

    MDR report key: 2278381 · Received September 20, 2011

    Report

    Report Number
    9617544-2011-00322
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K002858
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K060361. METHOD: VISUAL INSPECTION, MFG RECORD REVIEW. RESULT: VISUAL INSPECTION SHOWED MARK VISIBLE ON BONE SCREW HEAD SUPPORTING HIGH CONTACT PRESSURE APPLIED DURING TIGHTENING AND INDICATING BONE SCREW WAS VERY ANGULATED. OTHER MARKS INDICATE BONE SCREW WAS FIRMLY PUSHED DOWN IN TULIP SIGNIFYING FIRMLY LOCKED CONSTRUCT, HENCE SCREW-ROD-BLOCKER WERE TIGHTENED DURING SURGERY. COMPLAINT ANALYSIS - JAMMING OF SCREW HEAD IS A KNOWN BEHAVIOR OF POLYAXIAL SCREW AND NOT INDICATIVE OF A PRODUCT DEFECT. MFG RECORD REVIEW - MFG RECORDS WERE REVIEWED AND THERE WERE NO ISSUES CONTRIBUTING TO REPORTED EVENTS. RISK ASSESSMENT - POTENTIAL LIMITED ADD'L SURGERY TIME. CONCLUSION: POLYAXIAL SCREWS ARE DESIGNED TO LOCK WHEN FINAL TIGHTENED. COLD WELDING LOCKS THE SCREW AFTER FINAL TIGHTENING. WHEN THE SCREW IS PLACED AT AN ACUTE ANGLE (AS OBSERVED TO BE THE CASE HERE), THE SCREW CAN BECOME RIGIDLY COLD WELDED INTO THE TULIP. THE COLD WELDED TULIP DID NOT PREVENT SURGEON FROM REMOVING SCREW. SINCE LOCKING OF SCREWS IS INTENDED TO OCCUR BY DESIGN AFTER FINAL TIGHTENING TO RETAIN IMPLANTS IN PROPER POSITION AFTER SURGERY, THE EVENT DESCRIBED IN THIS COMPLAINT WOULD NOT BE CONSIDERED TO BE A NON-CONFORMITY. HENCE NO CORRECTIVE ACTION IS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED "6.5 X 50 POLYAXIAL XIA II SCREW DRIVE INTO PEDICLE. AFTER ROD AND SET SCREW WERE INSERTED, THE SET SCREW WOULD NOT SEAT IN TULIP HEAD. SET SCREW WAS REMOVED AND PHYSICIAN NOTICED TULIP HEAD WAS STUCK. AFTER USING MONOBLOCKER INSTRUMENT STILL COULD NOT MOVE SCREW HEAD. HE LOADED THE SCREW BACK ONTO SCREW DRIVER AND REMOVED THE SCREW. HE THEN TOOK A MALLET AND TRIED TO BREAK THE TULIP HEAD FREE, AND WAS UNABLE TO. HE THEN PLACED A 7.5 X 50 SCREW BACK INTO THE PEDICLE. WE EVENTUALLY GOT THE TULIP HEAD TO BREAK FREE FROM THE LOCKED POSITION BUT NOT AFTER COMPROMISING THE INTEGRITY OF THE SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 6.5 X 50MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA A90652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK