BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23850066 · Received December 19, 2025

    Report

    Report Number
    3005075696-2025-00412
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS INCLUDED IN THE ARTICLE. A2) THIS VALUE REPRESENTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REPRESENTS THE MAJORITY SEX OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A4) THE WEIGHT OF THE PATIENTS WAS NOT PROVIDED. A1) PATIENT IDENTIFIER(S) WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE ARTICLE'S ACCEPTED DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. 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

    SAGENLY, MALICK, ET AL. ¿IMPLEMENTATION OF ROBOT-ASSISTED SPINE SURGERY IN AN ACADEMIC CENTER: WORKFLOW, LEARNING CURVE AND PERSPECTIVES.¿ NEUROCHIRURGIE, VOL. 72, NO. 1, P. 13, HTTPS://DOI.ORG/10.1016/J.NEUCHI.2025.101741. ABSTRACT: SURGICAL ROBOTICS REPRESENT A SIGNIFICANT ADVANCEMENT IN HEALTHCARE, ENHANCING PRECISION AND SAFETY IN OPERATIVE PROCEDURES. WHILE WIDELY USED IN NEUROSURGERY, VISCERAL SURGERY, AND UROLOGY, ITS ADOPTION IN SPINAL SURGERY REMAINS IN DEVELOPMENT. THIS STUDY REPORTS THE IMPLEMENTATION OF ROBOTIC-ASSISTED SPINE SURGERY WITHIN A NEUROSURGICAL DEPARTMENT, FOCUSING ON THE LEARNING CURVE, WORKFLOW INTEGRATION, COMPLICATIONS, AND PROSPECTS. SUCCESSFUL INTEGRATION REQUIRES A DEDICATED TECHNICAL INFRASTRUCTURE AND THOROUGH TRAINING¿BOTH THEORETICAL AND PRACTICAL¿FOR THE ENTIRE SURGICAL TEAM. COLLABORATION AMONG SURGEONS, PARAMEDICAL STAFF, AND BIOMEDICAL ENGINEERS IS ESSENTIAL TO OPTIMIZE OUTCOMES. WE USED A TABLE-MOUNTED ROBOTIC SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC), WITH SURGICAL PLANNING BASED ON PREOPERATIVE, SUB-MILLIMETRIC BONE-DENSITY CT SCANS TO ENSURE PERSONALIZED CARE. FROM NOVEMBER 2022 TO MAY 2023, WE INCLUDED 32 PATIENTS WITH AN AVERAGE AGE OF 58 Y/O (SD 15 (19; 87)) FOR A TOTAL OF 204 INSERTED SCREWS. DEGENERATIVE SPINE REPRESENTED THE MAIN INDICATION FOLLOWED BY TUMORAL SPINE. OPTIMAL ACCURACY FOR PEDICLE SCREW PLACEMENT WAS 97 % CORRESPONDING TO GRADE A (90.1%) AND GRADE B (6.9%) FROM GRS. THE OPERATING TIME WAS OF 186.7 MIN (SD 89.7 (45; 386)) AND THE AVERAGE FLUOROSCOPY TIME PER SCREW WAS OF 3.0 S (1.8¿5.5). INSTALLATION IS A TIME-CONSUMING STEP. WE OBSERVED A TREND TOWARDS SHORTER OPERATING TIMES AS MORE CASES ARE OPERATED ON. NO REVISION SURGERY WAS NEEDED DURING THE STUDY PERIOD. ONLY 2 SUPERFICIAL SKIN INFECTIONS WERE REPORTED, WITH NO OTHER COMPLICATION. ROBOTIC SPINE SURGERY IMPROVES STANDARDIZATION, ENHANCES ACCURACY, AND PROMOTES PERSONALIZED MEDICINE, WITH POTENTIAL FOR FURTHER WORKFLOW OPTIMIZATION. REPORTED EVENTS: 2 SUPERFICIAL SKIN INFECTIONS WERE REPORTED, WITH NO OTHER COMPLICATION. 19-YEAR-OLD MALE WITHOUT ANY MEDICAL OR SURGICAL RECORDS HAD DYSESTHESIA OF THE RIGHT FLANK 2-MONTHS POST-OPERATIVELY. NO IMPACT ON QUALITY OF LIFE OR SPECIFIC COMPLAINTS WERE REPORTED. 19-YEAR-OLD FEMALE WITH PROGRESSIVELY WORSENING IDIOPATHIC SCOLIOSIS UNDERWENT ROBOTIC ASSISTED SURGERY HAD TRANSIENT PARAESTHESIA OF THE LEFT LOWER LIMB POST-OPERATIVELY. A TRANSFUSION OF RED BLOOD CELLS WAS PERFORMED. 6 SCREWS WERE REPORTED TO HAVE BEEN INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208787 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male