BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23686586 · Received December 1, 2025

    Report

    Report Number
    3005075696-2025-00390
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    July 31, 2025
    Report Date
    January 21, 2026
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109184524
    PMA / PMN Number
    K203005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    D4, G3, H4: CORRECTION TO SERIAL NUMBER, 510K NUMBER, AND MANUFACTURE DATE. 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 "PIF" FROM LEVELS T11-PELVIS ON 7/31. THE PATIENT WAS FOUND TO HAVE PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND UNDERWENT SURGERY TO REVERSE THIS. THE PATIENT WAS IMPROVING FOLLOWING INDEX THE SURGERY, BUT DEVELOPED MID BACK PAIN ALONG THE PROXIMAL ASPECT OF THE THORACOLUMBAR FUSION, WHICH WAS DIFFERENT FROM THE PATIENT'S PREOPERATIVE PAIN. THE PATIENT DENIED ANY LOWER EXTREMITY PAIN, PARESTHESIA, OR WEAKNESS, SADDLE PARESTHESIA OR BOWEL/BLADDER INCONTINENCE. ON IMAGING, THE PATIENT WAS FOUND TO HAVE A BURST FRACTURE OF T11 VERTEBRAE WITH PJK AT T10-11. THE PATIENT THEN UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, MEDICATION REFILLS, AND SUBSEQUENTLY AN EXTENSION FROM THEIR FUSION FROM T4-T1. THORACIC KYPHOSIS MEASURED AT 76 DEGREES, LUMBAR LORDOSIS MEASURED 59 DEGREES, PELVIC INCIDENCE MEASURED TO THE 70S, AND PELVIC TILT MEASURED AT 35 DEGREES. THE BILATERAL POSTERIOR INSTRUMENTED SCREW AND ROD FIXATION WAS PRESENT FROM T11 TO THE PELVIS. THE METALLIC INTERBODY DEVICES WERE PRESENT AT L4-5, L5-6, L6-S1 WITH ANTERIOR PLATE FIXATION AT L6-S1. THERE WAS PJK AT THE T10-11 LEVEL. OVERALL, THESE IMAGES WERE CONSISTENT WITH THORACOLUMBAR FUSION FROM T11 TO THE PELVIS WITH PJK AT T10-11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399802 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109184524

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization