BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 11738813 · Received April 28, 2021

    Report

    Report Number
    3005075696-2021-00047
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 6, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE SOFTWARE EXPORTS AND LOGS FOUND THE COMPLAINT WAS CONFIRMED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUORO IMAGES WERE CHECKED AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR X R<(>&<)>D WORKSTATION. ANALYSIS REVIEWED THE PLANNING OF THE EXECUTED TRAJECTORIES. NO SKIVING POTENTIAL WAS OBSERVED. ANALYSIS REPRODUCED THE REGISTRATION RESULTS. THE CT-FLUORO MATCH SCORE SHOWS ACCEPTABLE VALUES AND THE IMAGE MATCH SHOW NO OBSERVABLE SHIFTS. AS REPORTED: "THE SURGICAL ARM WAS SENT TO THE RIGHT TRAJECTORIES FIRST, L5 THEN S1, AND THEN TO THE LEFT TRAJECTORIES, L5 THEN S1. WHEN THE SURGICAL ARM WAS SENT TO THE L5 TRAJECTORIES, THE SYSTEM WAS INACCURATE. THE S1 TRAJECTORIES WERE ACCURATE." THE FACT THAT S1 TRAJECTORIES WERE ACCURATE AND THAT "THE SYSTEM PASSED AN ACCURACY TEST AFTER THE PROCEDURE AND ANOTHER PROCEDURE WAS COMPLETED WITHOUT ISSUE" ELIMINATES THE POSSIBILITY OF ARM INACCURACY. AS CAN BE SEEN BY IMAGES, AN INTERBODY WAS ADDED BEFORE OPERATION WHICH MAY HAVE LED TO SPINE INSTABILITY. AFTER RULING OUT, REGISTRATION SHIFT, SURGICAL ARM ACCURACY AND FAULTY AND SKIVING POTENTIAL, ANALYSIS CONCLUDED THE DEVIATIONS REPORTED WERE DUE TO L5 VERTEBRA INSTABILITY, RESULTING IN DISCREPANCY BETWEEN THE TOOLS AND THE POSITION OF THE ANATOMY OF THE TRAJECTORIES. THE FACT THAT S1 TRAJECTORIES WERE ACCURATE, FURTHER HIGHLIGHTS THIS PROBABLE CAUSE. 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 THAT THERE WAS A DEVIATION DURING THE CASE. WHEN GOING TO DO REGISTRATION FOR THE POSTERIOR PORTION OF THE PROCEDURE, THE SURGEON TRIED TAKING IMAGES GOING STRAIGHT DOWN THE INTERBODY, BUT SINCE IT WAS AT A HIGH ANGLE REGISTRATION COULD NOT BE COMPLETED. A NEW SET OF IMAGES WERE TAKEN WITH LESS OF AN ANGLE AND REGISTRATION WAS COMPLETED WITH GREEN VALUES AT EACH LEVEL. THE SURGEON DID NOT SEE ANY NOTICEABLE SHIFTS SO THE CASE WAS CONTINUED. THE SURGICAL ARM WAS SENT TO THE RIGHT TRAJECTORIES FIRST, L5 THEN S1, AND THEN TO THE LEFT TRAJECTORIES, L5 THEN S1.  WHEN THE SURGICAL ARM WAS SENT TO THE L5 TRAJECTORIES, THE SYSTEM WAS INACCURATE. THE S1 TRAJECTORIES WERE ACCURATE.  FLUORO SHOTS WERE DONE TO CONFIRM THE K-WIRE TRAJECTORIES. BOTH L5 TRAJECTORIES WERE 15 MM LOW AND LATERA. THE S1 TRAJECTORIES WERE PLACED WITH THE GUIDANCE SYSTEM AND THE L5 TRAJECTORIES WERE FREEHANDED.  THE SYSTEM PASSED AN ACCURACY TEST AFTER THE PROCEDURE AND ANOTHER PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE REPRESENTATIVE SUSPECTED SOMETHING WENT WRONG DURING REGISTRATION, BUT THEY WERE NOT SURE IF THAT CAUSED THE DEVIATIONS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635583 MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR