BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM

    MDR report key: 2961822 · Received February 14, 2013

    Report

    Report Number
    3005525032-2013-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    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, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE THREADS OF THE TULIP ARE DAMAGED. SUCH DAMAGES ARE SIMILAR TO A RESULT OF CROSS THREADING OF BLOCKER DURING ITS INSERTION TO THE SCREW TULIP. IN ADDITION, THE SEVERITY OF THREAD DEFORMATION SUGGESTS ABOUT APPLICATION OF SIGNIFICANT LOAD DURING INSERTION OF MISALIGNED BLOCKER. A VERY LARGE MARK OF A ROD IS VISIBLE ON THE BONE SCREW HEAD. IN ADDITION, IT IS SITUATED AT VERY EXTREMITY OF CYLINDRICAL TIP OF BONE SCREW HEAD. THIS POSITION OF THE MARK EVIDENCES THAT THE SCREW WAS IMPLANTED EXTREMELY BENT. FUNCTIONAL INSPECTION: NOT APPLICABLE AS THREADS OF TULIP ARE TOO DAMAGED, A BLOCKER CANNOT BE FITTED INTO THE SCREW TULIP. OTHERWISE, THE TULIP IS NOT LOCKED AND NOT DISENGAGED FROM THE BONE SCREW. DEVICE HISTORY REVIEW: MANUFACTURING FILES WERE REVIEWED FOR: BATCH #(B)(4) (SCREW ASSEMBLY) AND LOT #B24715 (TULIP). NO NON CONFORMITIES WERE FOUND DURING MANUFACTURING OF BOTH LOTS. RAW MATERIAL USED FOR MANUFACTURING OF SCREW TULIP (LOT #01023) WAS TESTED BY EXTERNAL LABORATORY AND FOUND CONFORM TO THE SPECIFICATION. COMPLAINT HISTORY: IN TOTAL 26 COMPLAINTS FOR TULIP SPLAY AND TULIP CROSS THREADING WERE FOUND. IT IS REPORTED THAT 33 SCREWS ARE INVOLVED. FAILURE WAS CONFIRMED FOR 18 IMPLANTS. CONCLUSION: THE TULIP OF THE RETURNED SCREW IS SIGNIFICANTLY DAMAGED. IT IS NOT FURTHER POSSIBLE TO INSERT ANY BLOCKER INSIDE THE TULIP. THE DAMAGE OF THREADS IS VERY SIMILAR TO THE RESULT OF CROSS THREADING. IN ADDITION, THE SEVERITY OF DAMAGE SUGGESTS ABOUT APPLICATION OF SIGNIFICANT LOAD DURING INSERTION OF MISALIGNED BLOCKER. IT SEEMS THAT THE SCREW WAS DAMAGED DURING INSERTION OF A MISALIGNED BLOCKER INSIDE TULIP WHILE THE SURGEON WANTED TO FIX A ROD. THE NOTICEABLE RESISTANCE FELT DURING BLOCKER INSERTION WAS IGNORED AND EXCESSIVE LOAD WAS APPLIED TO CONTINUE DRIVING A BLOCKER INTO THE SCREW. THUS THE THREADS WERE DAMAGED AND THE TULIP SPLAYED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED: ON (B)(6) 2013 TH9-ILIAC FIXATION SURGERY WITH XIA3 WAS PERFORMED. WHEN THE SURGEON TRIED TO FASTEN THE BLOCKER BEFORE COMPRESSION, THE BLOCKER WAS REBOUNDED BY THE ILIAC SCREW. ALTHOUGH HE TRIED AGAIN WITH OTHER NEW BLOCKER, SINCE THE SAME EVENT OCCURRED, HE REPLACED THE ILIAC SCREW. AFTER THAT THE SURGERY WAS FINISHED WITHOUT PROBLEM. THE SURGEON REQUESTS A CHECK OF WHETHER THE TULIP IS OPEN.

    Description of Event or Problem · 1

    AS REPORTED: ON (B)(6) 2013 TH9-ILIAC FIXATION SURGERY WITH XIA3 WAS PERFORMED. WHEN THE SURGEON TRIED TO FASTEN THE BLOCKER BEFORE COMPRESSION, THE BLOCKER WAS REBOUNDED BY THE ILIAC SCREW. ALTHOUGH HE TRIED AGAIN WITH OTHER NEW BLOCKER, SINCE THE SAME EVENT OCCURRED, HE REPLACED THE ILIAC SCREW. AFTER THAT THE SURGERY WAS FINISHED WITHOUT PROBLEM. THE SURGEON REQUESTS A CHECK OF WHETHER THE TULIP IS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64702 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM IMPLANT MNH STRYKER SPINE-SWITZERLAND B26198

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR