BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 14219046 · Received April 27, 2022

    Report

    Report Number
    3005075696-2022-00038
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 13, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109180465
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS OF THE SOFTWARE EXPORTS AND LOGS 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.

    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 RUNNING. ANALYSIS REVIEWED THE PLANNING MADE FOR THE CASE. THE AXIAL ANGLES PLANNED THROUGHOUT THE SEGMENT ARE ABOVE THE RECOMMENDED ANGLES IN OPEN CASES (7-12 DEGREES) ON ALL L4-S1 PLANNED TRAJECTORIES. TRAJECTORIES THAT ARE PLANNED WITH HIGH AXIAL ANGLES IN OPEN PROCEDURES MIGHT BE PRONE TO SOFT-TISSUE PRESSURE. LATERAL SKIVING POTENTIAL WAS FOUND OVER SACROILIAC JOINTS OBSERVED ON R S2 TRAJECTORY. IT WAS REPORTED THAT "THERE WERE MULTIPLE MISPLACED SCREWS DURING A PROCEDURE¿ ALL OF THE MISPLACED SCREWS WERE MEDIAL EXCEPT ONE OF THE S2 SCREWS¿ THE SCREWS WERE 3.5-10 MM OFF TRAJECTORY." ANALYSIS REVIEWED THE IMAGES PROVIDED IN THE EXPORT FILE. POST-OP IMAGES CONFIRM THAT MEDIAL DEVIATIONS OCCURRED ON ALL L4-S1 TRAJECTORIES (L+R SIDES). S2 RIGHT S CREW WAS CONFIRMED TO HAVE DEVIATED LATERALLY. AS REPORTED, THIS WAS AN OPEN-APPROACH SURGERY. THERE ARE NO AVAILABLE IMAGES OF THE RETRACTED SKIN. HOWEVER, SINCE THE MIDLINE INCISION IS FAR FROM THE SCREWS' ENTRY-POINT, COMBINED WITH THE HIGH AXIAL ANGLES, IT IS VERY PROBABLE THAT L4-S1 WERE SUBJECTED TO SOFT-TISSUE PRESSURE ON THE TOOLS. FROM THE POST-OP SCAN THE MEDIAL DEVIATION OF L4-S1 SCREWS CAN BE CONFIRMED. ANALYSIS REVIEWED THE LOG FILES PROVIDED. THE LOG FILES SHOW NO INDICATION OF EXCESSIVE FORCE BEING APPLIED. ANALYSIS REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THAT (1) THE ROOT CAUSE OF THE MEDIAL SHIFT IN L4-S1 TRAJECTORIES WAS SOFT TISSUE PRESSURE ON THE TOOLS, AND THAT (2) THE S2-RIGHT LATERAL TRAJECTORY SHIFT WAS CAUSED DUE TO SKIVING EITHER ON THE FACET JOINT OR ON THE SACROILIAC JOINT. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE MULTIPLE MISPLACED SCREWS DURING THE PROCEDURE. ALL OF THE MISPLACED SCREWS WERE MEDIAL BETWEEN 3.5-10 MM. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ ARM CONNECTED TO A SCHANZ PIN PLACED IN THE RIGHT PSIS. THE SURGEON WAS ON THE LEFT SIDE OF THE PATIENT AND IMPLANTED IPSILATERAL PEDICLE SCREWS FROM L4-S1. THE SURGEON THEN IMPLANTED IPSILATERAL L4-S1 FROM THE RIGHT SIDE. THEN THEY IMPLANTED A CONTRALATERAL S2AI SCREW FROM THE PATIENT'S RIGHT. THE SURGEON FINALLY IMPLANTED THE PATIENT'S RIGHT S2AI SCREW FROM THE LEFT SIDE OF THE PATIENT. ALL WERE MEDIAL EXCEPT ONE OF THE S2 SCREWS. AN ACCURACY CHECK HAD BEEN RUN AFTER PLACING THE L5 RIGHT AND THE SYSTEM APPEARED ACCURATE AT THAT TIME. NO PATIENT SHIFT OR SOFT TISSUE TENSION WAS NOTED WHEN PLACING THE SCREWS DURING THIS OPEN PROCEDURE. MINIMAL RETRACTION WAS NEEDED. THE MALIGNED SCREWS WERE NOTICED IN A POSTOP CT SCAN. THERE WAS NO SPIN PERFORMED TO CHECK THE PLACEMENT OF THE IMPLANTS INTRAOPERATIVELY. A SEPARATE REVISION WAS PLANNED TO REVISE THE SCREWS. THE PROCEDURE WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905046 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention