BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 11620654 · Received April 6, 2021

    Report

    Report Number
    3005075696-2021-00040
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 7, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE SOFTWARE EXPORT 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 IN ORDER 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 X STEALTH EDITION WORKSTATION. THE PLANNING MADE FOR THE CASE WAS REVIEWED. IT WAS NOTICED THAT THERE WAS A SKIVING POTENTIAL AT THE PLANNING OF BOTH TRAJECTORIES IN T11 VERTEBRA. REGISTRATION AND THE MATCHING ACCURACY OF THE SYSTEM WAS REVIEWED. THE CT-FLUORO MATCHING OF THE VERTEBRAE WERE DETERMINED ACCEPTABLE. THE NATURE OF THE DEVIATION WAS REVIEWED. T11 RIGHT TRAJECTORY WAS DEVIATED APPROXIMATELY 4 MM MEDIALLY WHILE THE LEFT TRAJECTORY DEVIATED APPROXIMATELY 4 MM LATERALLY. THE FIXATION PLATFORM USED WAS A SCHANZ SCREW CONNECTED TO BONE MOUNT BRIDGE IN THE RIGHT PSIS. ACCORDING TO SURGICAL TECHNIQUE GUIDE, WHEN USING A SCHANZ SCREW IN AN MIS CASE, THE APPROVED OPERATIONAL RANGE IS FROM S2 TO L1 VERTEBRAS. FURTHERMORE, IT WAS MENTIONED THAT L1 VERTEBRA WAS FRACTURED WHICH COULD CONTRIBUTE TO INSTABILITY OF THE ANATOMY. ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE ROOT CAUSE OF THE DEVIATIONS TO BE INADEQUATE FIXATION PLATFORM, MOST PROBABLY LEADING TO A PLATFORM SHIFT WHEN INSTRUMENTING T10, T11, T12 VERTEBRAS THAT WERE OUT OF THE SAFE OPERATIONAL RANGE. THE FRACTURED VERTEBRA (L1) MAY HAVE ALSO CONTRIBUTED TO THE INSTABILITY OF THE SYSTEM. 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

    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 A T11-L3 PSF WAS COMPLETED. THE CASE WAS MINIMALLY INVASIVE AND A SCHANZ ARM WAS USED TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT.  L1 WAS FRACTURED SO THE SCREWS AND RODS WERE PLACED MIS AND THEN THE PATIENT WAS FLIPPED LATERAL FOR THE CORPECTOMY. INTRA-OP IMAGES LOOKED GOOD AND PLACEMENT WAS CONFIRMED BY THE SURGEON. A FEW DAYS AFTER THE PROCEDURE, POST-OP SCANS SHOWED THAT LEFT T11 WAS LATERAL 4MM AND RIGHT T11 WAS MEDIAL BY 4 MM.  THE SURGEON PLANNED TO REVISE THE SCREWS. THE CAUSE OF THE DEVIATION WAS NOT DETERMINED. THE INITIAL PROCEDURE WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516811 MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention