BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23939613 · Received January 1, 2026

    Report

    Report Number
    3005075696-2026-00011
    Event Type
    Malfunction
    Date Received
    January 1, 2026
    Date of Event
    July 6, 2023
    Report Date
    January 1, 2026
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K203005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H7) THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH FA1523, 806 REPORT # 3005075696-12/16/2025-001-C. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: KIT1378, SOFTWARE VERSION: 5.0.1 AND KIT1378-05, SOFTWARE VERSION: 5.1.1. H3, H6) ANALYSIS WAS PERFORMED FOR THIS EVENT. IN SUMMARY, A SOFTWARE DEFECT WAS CONFIRMED FOR BOTH VERSIONS. CODES B01, C10, AND D18 ARE APPLICABLE. SECTION G2) K203005 PROVIDED FOR SOFTWARE VERSION 5.0.1. K230064 IS ALSO APPLICABLE AS IT CAPTURES SOFTWARE VERSION 5.1.1. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING INTERNAL TESTING IT WAS FOUND THAT ACCURACY IS AFFECTED AND COMPROMISED WHEN ADJUSTING PBRS POSITION FROM PLANNING (5.0.1) OR AXIS VALIDATION (5.1.1) AND RETURNING TO OPERATION IN DEFECT # 21991. IN BOTH VERSIONS: THE USER CAN EDIT THE PBRS AFTER EXITING OPERATION, ADJUSTING PBRS FROM PLANNING (5.0.1) OR AXIS VALIDATION (5.1.1) AND RETURNING TO OPERATION. THE REGISTRATION IS STILL 'VALID' FOR THE VERTEBRAE ¿ DIFFERENTLY AS IN POSTERIOR ELEMENTS SCREEN WHERE THE SW CLEARS THE APPROVED LEVELS. ACCURACY IS AFFECTED AND COMPROMISED ¿ WE SENT TO THE SAME BB BEFORE AND AFTER CHANGING THE PBRS AND THE ARM WAS SENT INTO TWO DIFFERENT TRAJECTORIES. AFTER CHANGING THE PBRS AND RETURNING BACK TO OPERATION, THE UI DISPLAYS "NOT ON TRAJECTORY". IF THE CHANGE IS SIGNIFICANT, UPON ENTERING APPROVE REGISTRATION SCREEN THERE IS A WARNING MESSAGE SAYING THAT REGISTRATION FOR VERTEBRAE X, Y, Z ARE AFFECTED DUE TO MULTIPLE POSSIBLE REASONS (DON'T REMEMBER EXACTLY THE WORDING BUT IT IS SOMETHING IN GENERAL). HOWEVER, IF THE CHANGE IS MINOR - NO INDICATION IS PRESENTED TO THE USER. THE WARNING MESSAGE IS NOT ALWAYS CONSISTENT WITH THE VERTEBRA WE CHANGED ITS PBRS ¿ ONCE WE CHANGED L2 AND WE GOT THE WARNING FOR L1. NAVIGATION ACTS SIMILAR TO A REGULAR CASE WHERE A PATIENT SHIFT OCCURS. CHECKING NAVIGATION ACCURACY SHOWS THAT WE ARE ACCURATE (PASSIVE PLANAR IS WITHIN THE ARM GUIDE DIVOT). ONLY WHEN CHECKING THE ANATOMY, THEY CAN SEE THAT PHYSICALLY THEY ARE ON ONE ANATOMICAL LANDMARK WHILE THE NAVIGATION SHOWS DIFFERENTLY. THIS MEANS THAT IN A REGULAR FLOW NAVIGATION THE USER WILL NOT UNDERSTAND THE SHIFT BY VISUALIZING THE NAVIGATION WHEN EXECUTING THE TRAJECTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown