BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 3113698 · Received May 15, 2013

    Report

    Report Number
    3005525032-2013-00045
    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 WERE EXAMINED UNDER A MICROSCOPE. THE BLOCKER RELATED TO THIS INVESTIGATION HAD DEFORMATION CONSISTENT WITH 12 NM TIGHTENING FORCE. THERE WAS ALSO AN IMPRINT ON THE BACK OF THIS BLOCKER FROM THE RETURNED ROD THAT THE BLOCKER HAD BEEN HOLDING IN THE CONSTRUCT. FUNCTIONAL INSPECTION: ONE OF THE RETURNED POLYAXIAL SCREWS IS STUCK AT ITS CURRENT ANGLE, IT HAS LOST ITS POLYAXIALITY. THE BLOCKERS WERE ABLE TO THREAD INTO THE RETURNED SCREWS INDICATING THAT THE THREADS ARE INTACT. 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 PARTICULAR BLOCKER RELATED TO THIS INVESTIGATION DID APPEAR TO BE TIGHTENED WITH A 12 NM FORCE AS SUGGESTED IN THE SURGICAL TECHNIQUE FOR XIA 3. 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
    214007 XIA 3 TITANIUM BLOCKER XIA 3 TITANIUM BLOCKER NKB STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R