BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 24730014 · Received March 30, 2026

    Report

    Report Number
    3005075696-2026-00077
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    April 17, 2023
    Report Date
    March 30, 2026
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A2-A4: PATIENT INFORMATION WAS NOT AVAILABLE. H3,H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY FOUND THE SYSTEM FUNCTIONED AS INTENDED. MULTIPLE PATIENT CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. E2302 - UNABLE TO MOVE RIGHT LOWER EXTREMITY E0123 - PERMANENT NERVE DAMAGE E020203 - EMOTIONAL DISTRESS E0307 - FLUID LEAK IN THE AREA OF THE SURGERY E2330 - EXTREME PAIN E232402 - LOSS OF BLADDER FUNCTION E232401 - LOSS OF BOWEL FUNCTION 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 PATIENT UNDERWENT THE PROCEDURE TO ADDRESS THEIR LUMBAR SPINE, AS THEY WERE EXPERIENCING PAIN AND SYMPTOMS RADIATING INTO THE LEFT HIP, GROIN, AND BUTTOCKS. DURING THE PROCEDURE, AFTER SCREWS WERE PLACED, AND PRIOR TO DECOMPRESSION, THE PATIENT LOST VIRTUALLY ALL MOTOR FUNCTION OF HER RIGHT LOWER EXTREMITY AND IN OTHER NERVE DISTRIBUTIONS. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ADDRESSING THE LOSS IN MOTOR FUNCTION, AND THE PHYSICIAN INDICATED THE CASE WAS COMPLETED WITHOUT COMPLICATION. POST-OPERATIVELY, THE PATIENT REPORTED THAT THEY WERE UNABLE TO MOVE THEIR RIGHT LOWER EXTREMITY. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY, WITH NO INDICATION OF US OF THE GUIDANCE SYSTEM, TO REMOVE OLD HARDWARE THAT WAS PRESENT PRIOR TO THE INITIAL PROCEDURE. THE PHYSICIAN PERFORMED A REVISION OF THEIR DECOMPRESSION, AND NOTED A LARGE DURAL DEFECT ON THE RIGHT, WHICH WAS REPAIRED THROUGH THE USE OF SUTURES, A TACHOSIL PATCH, AND SURGICAL GLUE. THE SURGEON DOCUMENTED THAT THE REMOVAL OF THE OLD HARDWARE CREATED THE DURAL DEFECT AND FLUID LEAK. AFTER THE SECOND PROCEDURE, THE PATIENT CONTINUED TO SUFFER FROM THE LOSS OF MOTOR FUNCTION IN THEIR RIGHT LOWER EXTREMITY, AS WELL AS BOWEL AND BLADDER INCONTINENCE AND EXTREME PAIN. THEN ON (B)(6) 2023, THE PATIENT PRESENTED AGAIN WITH EXTREME INTRACTABLE PAIN. IT WAS FOUND THAT THERE WAS A MASSIVE FLUID LEAK IN THE AREA OF THE SURGERY, WHICH WAS COMPRESSING THE AREA OF THE THECAL SAC AND CAUDA EQUINA, WITH FINDINGS INDICATIVE OF ARACHNOIDITIS AND INFECTION AND THUS SHE WAS IMMEDIATELY ADMITTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, BUT STILL SUFFERED FROM LOSS OF BOWEL AND BLADDER FUNCTION, TOGETHER WITH LOSS OF MOTOR FUNCTION IN THEIR RIGHT LOWER EXTREMITY AND EXCRUCIATING PAIN REQUIRING ONGOING SIGNIFICANT MEDICAL CARE, EVALUATION, AND TREATMENT. THESE ISSUES HAVE CAUSED THE PATIENT EMOTIONAL DISTRESS. THE PATIENT ALLEGED THEY SUFFERED PERMANENT NERVE DAMAGE DURING THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258015 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1