BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 20954162 · Received December 17, 2024

    Report

    Report Number
    3005075696-2024-00184
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    October 4, 2021
    Report Date
    December 17, 2024
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS AVAILABLE ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE.¿ B.5. INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. 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

    PROD¿HOMME, M., GRASSET, D., LÉVY, S., DIETRICH, G., HELFER, L., <(>&<)> BOSCHERINI, D. (2021). FLUORO-REGISTERED MAZOR X STEALTH EDITION VERSUS O-ARM NAVIGATION: PRELIMINARY RESULTS OF THE FIRST 21 PATIENTS. BRAIN AND SPINE, 1, 100169. HTTPS://DOI.ORG/10.1016/J.BAS.2021.100169 SUMMARY BACKGROUND CONTEXT: PEDICLE SCREW INSERTION FOR SPINAL FUSION IS A SURGICAL PROCEDURE REGULARLY PERFORMED AROUND THE WORLD. SURGICAL NAVIGATION SYSTEMS PROVIDE PEDICLE SCREW INSERTION BY PROJECTING SCREW TRAJECTORIES ON A THREE-DIMENSIONAL (3D) IMAGE ACQUISITION, PREOPERATIVELY OR DURING THE SURGICAL PROCEDURE, WITH HIGHER ACCURACY AND SAFETY. ROBOTIC GUIDANCE ASSISTS THE SURGEON THROUGH MECHANICAL GUIDANCE ACCORDING TO A PLANNING OF SCREW TRAJECTORIES ON 3D IMAGING AND ALLOWS STABLE GUIDANCE FOR PEDICLE DRILLING AND SCREW INSERTION, LEADING TO GREATER SCREW POSITIONING IN LUMBAR FUSION. MEDTRONIC INTRODUCED THE MAZOR X STEALTH IN EUROPA IN 2019, INCLUDING THE MAZOR X ROBOTIC DEVICE WITH THE NAVIGATION TECHNOLOGY WITHIN THE SAME SYSTEM. PURPOSE: THE GOAL OF THIS STUDY WAS TO COMPARE RADIOLOGICAL AND CLINICAL RESULTS AS WELL AS RADIATION EXPOSURE OF THE USE OF THE NEW MAZOR X STEALTH WITH THE O-ARM NAVIGATION DURING PEDICLE SCREW INSERTION FOR POSTERIOR LUMBAR FUSION. MATERIAL <(>&<)> METHODS: ALL FIRST CONSECUTIVE PATIENTS OPERATED FOR A SCREW INSERTION PROCEDURE FOR TRANS-FORAMINAL LUMBAR INTERBODY FUSION WERE PROSPECTIVELY ENROLLED IN THE STUDY. DEMOGRAPHIC DATA WERE COLLECTED, SUCH AS AGE, WEIGHT, HEIGHT, BODY MASS INDEX (BMI), AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) SCORE, PREOPERATIVE BACK AND LEG PAIN-VISUAL ANALOG SCALE (VAS) AND OSWESTRY DISABILITY INDEX (ODI). SURGICAL DATA WERE ALSO REPORTED AS FOLLOWS: LEVEL OPERATED, OPERATIVE TIME (IN MINUTES, MIN), WITH SPECIFIC PROCEDURE NV OR RG DURATION (IN MINUTES) FOR SCREW IMPLANTATION, OVERALL BLOOD LOSS (IN MILLILITERS, ML), COMPLICATIONS. IRRADIATION DATA SUCH AS DOSE AREA PRODUCT AND DOSE LENGTH PRODUCT FOR THE CALCULATION OF THE EFFECTIVE DOSE E (IN MILLISIEVERT, MSV). RADIOLOGICAL RESULTS WERE ASSESSED USING THE HEARY AND GERTZBEIN CLASSIFICATIONS FOR SCREW ACCURACY. RESULTS: 21 PATIENTS WERE INCLUDED SO FAR. 10 IN THE RG AND 11 IN THE NV GROUP. THE GROUPS WERE SIMILAR IN TERMS OF AGE, GENDER, BMI AND ASA SCORES. THERE WAS NO DIFFERENCE IN CLINICAL RESULTS OF VAS AND ODI. A TOTAL OF 88SCREWS ON 46 VERTEBRAE WERE INSERTED, 44 SCREWS IN EACH GROUP. THE ONLY SIGNIFICANT DIFFERENCE BETWEEN THE GROUP WAS OBSERVED FOR THE HIGHER OPERATIVE TIME DURATION IN THE RG GROUP: 140 VERSUS 109 MINUTES IN THE NV GROUP, P ¼ 0.03. OTHER COMPARISONS SHOWED NO SIGNIFICANT DIFFERENCES BETWEEN THE RG AND NV GROUPS, RESPECTIVELY FOR: SCREW IMPLANTATION DURATION (3.31 VERSUS 3.49 MIN, P ¼ 0.69), BLOOD LOSS (360 VERSUS 322 ML, P ¼ 0.60), E (8.30 VERSUS 6.41 MSV P ¼ 0.16). SCREW ACCURACY WAS SATISFACTORY FOR 98% IN THE RG GROUP AND 100% IN THE NV GROUP, WITHOUT SIGNIFICANT DIFFERENCE (P ¼ 1). CONCLUSION: THE PRELIMINARY RESULTS OF THE NEW ROBOTIC MAZOR X STEALTH EDITION SHOWED NO INFERIORITY TO THE O-ARM NAVIGATION AND SIMILAR SAFETY IN TERMS OF SCREW ACCURACY AND RADIATION EXPOSURE. REPORTED EVENT TEN PATIENTS UNDERWENT A SPINAL FUSION WITH ROBOT GUIDANCE ASSISTANCE. OF THE FORTY FOUR SCREWS INSERTED IT WAS NOTED THAT 98% OF THEM WERE ACCURATE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239849 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown