BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 3113757 · Received May 15, 2013

    Report

    Report Number
    3005525032-2013-00046
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: ALL RETURNED BLOCKERS (5 TOTAL) WERE EXAMINED UNDER A MICROSCOPE. THE BLOCKER RELATED TO THIS INVESTIGATION (MES) DID NOT HAVE ANY DEFORMATION ON ITS INTERIOR HEX PERIMETER; THIS IS NOT CONSISTENT WITH THE SUGGESTED APPLICATION OF A 12 NM TIGHTENING FORCE. THERE WAS ALSO NO IMPRINT ON THE BACK OF THIS BLOCKER FROM THE RETURNED ROD THAT THE BLOCKER HAD BEEN HOLDING IN THE CONSTRUCT, WHICH IS ALSO NOT EXPECTED IF THE CONSTRUCT IS PROPERLY TIGHTENED. ONE OF THE RETURNED BONE SCREWS ((B)(4)) HAD 2 DENTS ON THE HEAD, INDICATING MULTIPLE TIGHTENINGS. ONE OF THE DENTS WAS CONSISTENT WITH A 12 NM TIGHTENING FORCE AND THE OTHER DENT WAS NOTICEABLY SMALLER. THIS WOULD INDICATE THAT ONE OF THE BLOCKERS HAD BEEN TIGHTENED INTO THE SCREW MULTIPLE TIMES AFTER THE SCREW WAS READJUSTED. HOWEVER, NONE OF THE BLOCKERS HAVE DEFORMATION INDICATING MULTIPLE TIGHTENINGS, SO IT IS POSSIBLE THAT THE SCREW WAS TIGHTENED AT FIRST WITH ONE BLOCKER AND THEN REPLACED WITH A SECOND BLOCKER. THE SECOND RETURNED BONE SCREW ((B)(4)) HAS NO DENT OR DEFORMATION OF ANY KIND TO THE SCREW HEAD. THIS WOULD INDICATE THAT THIS SCREW AND IT'S BLOCKER WERE NOT TIGHTENED TO THE SUGGESTED 12 NM INDICATED ON THE TORQUE WRENCH. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE EVENT OF BLOCKER DISENGAGEMENT WAS CONFIRMED BY X-RAY IMAGES WHERE LOOSENING IS VISIBLE. 5 BLOCKERS, 2 SCREWS, AND 1 ROD WERE RETURNED AND IT COULD NOT BE VERIFIED WHICH TWO BLOCKERS HAD DISENGAGED AND WHICH 3 WERE CONSIDERED "LOOSE" BY THE SURGEON. THE RETURNED BLOCKER, BONE SCREW, AND ROD WERE VISUALLY AND FUNCTIONALLY INSPECTED. THE BLOCKER RELATED TO THIS INVESTIGATION (MES) DID NOT HAVE ANY DEFORMATION ON ITS INTERIOR HEX PERIMETER; THIS IS NOT CONSISTENT WITH THE SUGGESTED APPLICATION OF A 12 NM TIGHTENING FORCE. THERE WAS ALSO NO IMPRINT ON THE BACK OF THIS BLOCKER FROM THE RETURNED ROD THAT THE BLOCKER HAD BEEN HOLDING IN THE CONSTRUCT, WHICH IS ALSO NOT EXPECTED IF THE CONSTRUCT IS PROPERLY TIGHTENED. THE DISENGAGEMENT OR LOOSENING OF THIS PARTICULAR BLOCKER IS LIKELY DUE TO INSUFFICIENT TIGHTENING OF THE ENTIRE CONSTRUCT THAT LED TO HIGHER STRESS ON THE IMPLANTS. PER THE IFU, IMPLANTS DO NOT REPLICATE THE STRENGTH AND MECHANICS OF REGULAR BONE AND HIGH STRESS CAN LEAD TO FAILURE. ACCORDING TO THE REVIEW OF COMPLAINTS RECEIVED FOR SIMILAR ISSUES, POSTOPERATIVE DISENGAGEMENT OF THE BLOCKER FROM THE SCREW TULIP CAN BE LINKED WITH SUB OPTIMAL CONSTRUCT LOCKING CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TWO XIA 3 BLOCKERS BECAME DISENGAGED FROM SCREW HEADS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TWO XIA 3 BLOCKERS BECAME DISENGAGED FROM SCREW HEADS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214078 XIA 3 TITANIUM BLOCKER XIA 3 TITANIUM BLOCKER NKB STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R