BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 14621759 · Received June 7, 2022

    Report

    Report Number
    3005075696-2022-00048
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 30, 2022
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H3: A SOFTWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. THE INVESTIGATING TEAM CONCLUDED THE ROOT CAUSE OF THE DEVIATION OF LEFT L4 WAS DUE TO SOFT-TISSUE PRESSURE BEING APPLIED ON THE TOOLS WHILE INSTRUMENTING, WHICH RESULTED IN MEDIALLY DEVIATED TRAJECTORIES. HOWEVER, AS LEFT L4 WAS THE LAST TRAJECTORY EXECUTED, A PLATFORM OR PATIENT SHIFT CANNOT BE RULED OUT. 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 WAS A DEVIATION DURING A L4/L5 CASE. THE LEFT L4 SCREW WAS MEDIAL AND BREACHED THE CANAL. NAVIGATION WAS USED WITH THE DILATOR, BUT NOT WHEN PLACING THE SCREWS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE PSIS. ACCURACY WAS NOT CHECKED THROUGHOUT THE PROCEDURE. THE SURGEON DID NOT THINK THE DEVIATION WAS DUE TO THE GUIDANCE SYSTEM AND THEY THOUGHT THE RETRACTOR PUSHED THE CANNULA MEDIALLY. THE AMOUNT OF DEVIATION WAS UNKNOWN. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND THE SCREW WAS REPOSITIONED USING NAVIGATION. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645460 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other