BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23878702 · Received December 23, 2025

    Report

    Report Number
    3005075696-2025-00427
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    April 17, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) NO PARTS HAVE RETURNED TO THE MANUFACTURER FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. H6) MULTIPLE ANNEX E CODES WERE APPLIED TO CAPTURE PATIENT IMPACT. SEE BELOW FOR CLARIFICATIONS. E013403 - PARESTHESIA E1621 - WEAKNESS E2330 - PAIN E0139 - FOOT DROP. 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 FOLLOWING A SPINAL SURGERY, THE PATIENT WAS INITIALLY DOING WELL, BUT LATER DEVELOPED PROGRESSIVELY WORSENING LOW BACK PAIN (LEFT GREATER THAN RIGHT) AND LEFT LOWER-EXTREMITY PAIN OVER SEVERAL MONTHS. SYMPTOMS INCLUDED PAIN, PARESTHESIA'S, WEAKNESS, AND OCCASIONAL SENSATION OF LEFT-SIDED FOOT DROP; NO BOWEL OR BLADDER INCONTINENCE WAS REPORTED. PAIN WAS CONSTANT TO SOME DEGREE AND WORSENED WITH PROLONGED POSITIONING, RESEMBLING SYMPTOMS PRIOR TO THE PATENT'S ORIGINAL BERTOLOTTI'S FUSION. IT WAS SUGGESTED THAT MICROMOTION AT THE LEFT BERTOLOTTI'S JOINT POSSIBLY CONTRIBUTED TO SYMPTOMS, WITH RESIDUAL HARDWARE ALSO CONSIDERED AS A POTENTIAL FACTOR. THE PATIENT UNDERWENT A LEFT-SIDED BERTOLOTTI JOINT RESECTION AND REMOVAL OF RIGHT-SIDED INSTRUMENTATION AT L6/S1.POST-OPERATIVELY, LOW BACK AND LOWER EXTREMITY SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828925 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization