BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 11832472 · Received May 17, 2021

    Report

    Report Number
    3005075696-2021-00059
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    May 2, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109180465
    PMA / PMN Number
    K180307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE SOFTWARE EXPORTS WAS COMPLETED. THE CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE EXPORT FILE WAS GENERATED BY THE MAZOR X SYSTEM AND INCLUDES RECORDS OF ALL THE DATA THAT WAS USED AND GENERATED BY THE SYSTEM DURING THE CASE, INCLUDING BUT NOT LIMITED TO THE INTRA-OPERATIVE SCANS, PREOPERATIVE PLANNING, PROCEDURE ACTIONS THAT WERE EXECUTED, AND THE LOG TEXT FILE. THE LOG TEXT FILE IS A CHRONOLOGIC DOCUMENTATION OF THE SOFTWARE DURING OPERATION, INCLUDING SYSTEM SENT TRAJECTORIES, REGISTRATIONS VALUES, FLUORO ACQUISITION, ETC. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUOROSCOPIC IMAGES WERE CHECKED, AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR WORKSTATION. THE PLANNING MADE FOR THE CASE WAS REVIEWED. T7 LEFT AND T8 LEFT HAVE VERY SMALL PEDICLES. SMALL SUPERIOR BREACH IS PLANNED ON T7, AND ON T8 THERE IS VERY SMALL ROOM FOR ERROR. SLIGHT LATERAL DEVIATION COULD LEAD TO SUPERIOR BREACH INTO THE DISC. REGISTRATION WAS REVIEWED. REGISTRATION WAS REMADE, VERIFIED, AND COMPARED TO THE ONE USED IN THE CASE. SMALL INACCURACIES OBSERVED, ABOUT 1-1.5MM FOR T5, T6, T7 AND T8. THE NATURE OF THE DEVIATION WAS REVIEWED. THE REPORTED DEVIATIONS EXPERIENCED IN THE OR WERE: T5 RIGHT AND T6 RIGHT ¿ MEDIAL DEVIATION (NOT DRILLED), T5 LEFT (NOT DRILLED) LATERAL DEVIATION. WHEN EXAMINING THE CONFIRMATION IMAGE PROVIDED, IT CAN BE SEEN THAT T8 AND T7 LEFT ¿ SCREWS DEVIATED SUPERIORLY, GOING INTO THE DISC SPACES. SURGEON CHOSE NOT TO RE-REGISTER AND ABORT THE USE OF THE GUIDANCE SYSTEM. ANALYSIS REVIEWED THE SURGICAL WORKFLOW AND DETERMINED THAT FOR T7 AND T8, DUE TO THE SMALL PEDICLES AND POTENTIALLY A SMALL ERROR, K-WIRES BREACHED THE SUPERIOR WALL ON THE PEDICLE AND SCREWS MAY HAVE FOUND A NEW PATH, BREACHING SUPERIORLY. FOR T5 AND T6, THE DEVIATIONS REPORTED HAD A PATTERN - LATERAL ON THE LEFT SIDE AND MEDIAL ON THE RIGHT SIDE WHICH IS A CLEAR INDICATION FOR PATIENT SHIFT. POTENTIALLY, RETRACTION OF SOFT TISSUES ON THE RIGHT SIDE (T9/T10) MOVED THE PATIENT TO THE RIGHT, CAUSING MEDIAL DEVIATIONS ON THE RIGHT SIDE AND LATERAL DEVIATIONS ON THE LEFT SIDE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED A T4-T12 OPEN SCOLIOSIS CASE WAS DONE USING A BRIDGE AND DUAL CLAMPS PLACED ON THE SPINOUS PROCESSES OF T8 AND T10/T11. PRIOR TO THE OPERATION, THE MANUFACTURER REPRESENTATIVE RAN A 10 POINT ACCURACY CHECK, CHECKED ALL OF THE CAMERAS, AND CHECKED ALL OF THE CONNECTIONS TO ENSURE THERE WERE NO LOOSE CONNECTIONS OR FOREIGN OBJECTS THAT COULD CAUSE ISSUES. DURING THE PROCEDURE, THE SURGEON SECURED THE MOUNT. THE REPRESENTATIVE NOTED THAT THE PLAN WAS TO REACH T4 AND T5 WHILE THE CLAMP WAS OVER T8, BUT THEY NEVER GOT TO THOSE TRAJECTORIES. THE 3DEFINE SCAN WAS DONE AND REGISTRATION WAS COMPLETED WITHOUT ANY NOTICEABLE MOVEMENT. ONE SURGEON WORKED ON THE PATIENT'S LEFT SIDE AND ANOTHER SURGEON WORKED ON THE RIGHT SIDE OF THE PATIENT. THE SURGEON STARTED AT T12 AND MOVED UP IN A ZIG ZAG PATTERN. THE SURGEON WORKING ON THE LEFT SIDE DECIDED TO SKIP A FEW TRAJECTORIES AS THE MOUNT WAS OBSTRUCTING THE TRAJECTORIES. WHEN AT RIGHT T6, THE SURGEON FELT THE TRAJECTORY WAS MEDIAL TO PLAN BY LESS THAN 3.5 MM. THE SURGICAL ARM WAS SENT TO THE CLEAR UP POSITION AND BACK TO THE TRAJECTORY, BUT IT WENT TO THE SAME POSITION. PLANNING WAS ADJUSTED TO MAKE THE SCREW MORE LATERAL. THE SURGICAL ARM WAS SENT TO THE TRAJECTORY, BUT IT WAS AGAIN MEDIAL TO PLAN. THE SURGEON MOVED ON TO LEFT T8. WHEN THE SURGICAL ARM REACHED THE LOCATION, IT LOOKED LIKE IT WAS AT THE TRAJECTORY OF A PREVIOUS SCREW. THE SURGICAL ARM WAS THEN SET TO RIGHT T5 AND SHOWED MEDIAL TO THE PLAN SO THE ARM WAS SENT TO LEFT T5 AND WAS LATERAL TO PLAN. THE REPRESENTATIVE SUGGESTED THE PATIENT BE RE-REGISTERED DUE TO THE DEVIATIONS, BUT THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND COMPLETE THE CASE FREEHAND. ONCE THE SURGICAL SYSTEM WAS UNMOUNTED FROM THE BED, FLUORO IMAGING SHOWED DEVIATIONS AT LEFT T7 AND LEFT T8. THE SCREWS WERE PLACED INFERIOR AND HIT THE DISK SPACE. THE CAUSE OF THE DEVIATIONS WAS NOT DETERMINED. THE SURGICAL TEAM SUSPECTED IT WAS THE GUIDANCE SYSTEM. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED OVER AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731568 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR