BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 24203690 · Received January 28, 2026

    Report

    Report Number
    3005075696-2026-00035
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    November 6, 2025
    Report Date
    February 19, 2026
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109180465
    PMA / PMN Number
    K230064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SURGICAL ARM WAS REPLACED AND THE UNIT THEN WORKED AS INTENDED. CODES B01, C07, AND D02 ARE APPLICABLE TO THIS ANALYSIS. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID:ASM0206-01S, SERIAL NUMBER: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    H3, H6: THE SURGICAL ARM, SERIAL NUMBER: (B)(6), WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND AN ENCODER FAILURE, REPEATER CARD FAILURE, FAULTY MOTOR/MOTOR ISSUE, MECHANICAL/MECHANICAL PART FAILURE, DAMAGED SCREWS, USB COVER ISSUE, PLASTIC COVER ISSUE, INTEL CAMERA OLD VERSION, HARMONIC DRIVE FAILURE, DRIVER FAILURE, SHOULDER HANDLE MALFUNCTION, SPACE MOUSE HANDLE OLD VERSION OR FAULTY, INTEL CAMERA BROKEN COVER, AND THE NAV TEST FAILED. CODES B01, C07, AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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.

    Additional Manufacturer Narrative · 0

    H6: CLINICAL DATA WAS RECEIVED AND IS CURRENTLY UNDERGOING ANALYSIS. CODES B21, C21, AND D16 ARE APPLICABLE. H6: MULTIPLE ANNEX E CODES WERE APPLIED TO CAPTURE PATIENT'S OUTCOME. E1621 REFERS TO THE WEAKNESS AND E2330 REFERS TO THE PAIN. 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 DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PLANNED SURGICAL TRAJECTORIES WERE HIGHER ON THE PATIENT THAN INTENDED (TOWARDS THE HEAD). AFTER ADJUSTING THE ANGLE OF THE C-ARM, THE SURGERY PROCEEDED. FOLLOWING THE INITIAL SURGERY, IT WAS DETERMINED THAT SCREWS HAD BEEN MISPLACED, AND THE PATIENT REQUIRED A RETURN TO SURGERY FOR MANUAL SCREW PLACEMENT (REVISION SURGERY). THE PATIENT REPORTED LEFT LEG PAIN AND WEAKNESS FOLLOWING THE INITIAL SURGERY, WHICH LESSENED AFTER THE REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORY DEVIATION WAS LIKELY IN THE 3.5-10 MILLIMETER (MM) RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266339 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other SEE H11...