BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 13625894 · Received February 28, 2022

    Report

    Report Number
    3005075696-2022-00020
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    October 20, 2020
    Report Date
    February 28, 2022
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: DU J, GAO L, HUANG D, SHAN L, WANG W, FAN Y, HAO D, YAN L. RADIOLOGICAL AND CLINICAL DIFFERENCES BETWEEN ROBOTIC-ASSISTED PEDICLE SCREW FIXATION WITH AND WITHOUT REAL-TIME OPTICAL TRACKING. EUROPEAN SPINE JOURNAL. 2021: 30:142-150. HTTPS://DOI.ORG/ 10.1007/S00586-020-06641-Y. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT: TO STUDY RADIOLOGICAL AND CLINICAL DIFFERENCES BETWEEN ROBOTIC-ASSISTED PEDICLE SCREW FIXATION WITH AND WITHOUT REAL-TIME OPTICAL TRACKING. PATIENTS WHO UNDERWENT LUMBAR INTERNAL FIXATION IN OUR HOSPITAL FROM JUNE 2017 TO FEBRUARY 2020 WERE DIVIDED INTO TINAVI GROUP (WITH OPTICAL TRACKING) AND RENAISSANCE GROUP (WITHOUT OPTICAL TRACKING) ACCORDING TO ASSISTED TECHNOLOGY. THE IMAGING DATA OF THE PATIENTS WERE COLLECTED, AND THE ACCURACY OF SCREW IMPLANTATION WAS MEASURED ACCORDING TO RAMPERSAUD A¿D GRADE. CLINICAL OUTCOMES SUCH AS OPERATIVE TIME, FLUOROSCOPIC TIME AND RADIATIONS DOSE WERE ALSO COLLECTED. A TOTAL OF 376 PATIENTS WERE INCLUDED, INCLUDING 201 PATIENTS IN THE TINAVI GROUP WITH 968 SCREWS IMPLANTED AND 175 PATIENTS IN THE RENAISSANCE GROUP WITH 822 SCREWS IMPLANTED. THE ACCURACY OF "PERFECT" AND "CLINICALLY ACCEPTABLE" PEDICLE SCREW IMPLANTATION IN THE TINAVI GROUP WAS 94.9%¿98.7%, RESPECTIVELY, WHILE IN THE RENAISSANCE GROUP WAS 91.2%¿94.5%, RESPECTIVELY. THERE WAS SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS (P < >0.05). THE OPERATIVE TIME AND OPERATIVE TIME PER SCREW IN THE TINAVI GROUP WERE LOWER THAN THOSE IN THE RENAISSANCE GROUP. HOWEVER, FLUOROSCOPIC TIME PER SCREW AND RADIATIONS DOSE OF THE TINAVI GROUP WERE SIGNIFICANTLY HIGHER THAN THOSE OF THE RENAISSANCE GROUP. OPTICAL TRACKING IN ROBOTIC SYSTEM APPEARS TO INCREASE ACCURACY BECAUSE OF THE ABILITY TO DETECT THE REAL-TIME POSITION OF THE PATIENT. ALTHOUGH THERE ARE STILL MANY PROBLEMS TO BE SOLVED, ROBOT WITH OPTICAL TRACKING SYSTEM SHOWS ITS GREAT POTENTIAL IN CLINICAL APPLICATION. REPORTED EVENTS TWO PATIENTS UNDERGOING LUMBAR INTERNAL FIXATION USING THE GUIDANCE SYSTEM EXPERIENCED DEVIATIONS THAT REQUIRED REVISION PROCEDURES DUE TO THE SCREW PENETRATING THE PEDICLE CORTEX AND STIMULATING THE NERVE ROOT. THE PATIENT EXPERIENCED NEUROLOGICAL COMPLICATIONS RELATED TO THE SCREW. ONE PATIENT UNDERGOING LUMBAR INTERNAL FIXATION USING THE GUIDANCE SYSTEM EXPERIENCED POST-OPERATIVE INFECTION. 3 - 27 SCREWS PLACED USING THE GUIDANCE SYSTEM DURING LUMBAR INTERNAL FIXATIONS PROCEDURES WERE DEVIATED AND PENETRATED THE PEDICLES CORTEX LESS THAN 2 MM. 4 - 9 SCREWS PLACED USING THE GUIDANCE SYSTEM DURING LUMBAR INTERNAL FIXATIONS PROCEDURES WERE DEVIATED AND PENETRATED THE PEDICLES CORTEX BETWEEN 2 AND 4 MM. 5 - 36 SCREWS PLACED USING THE GUIDANCE SYSTEM DURING LUMBAR INTERNAL FIXATIONS PROCEDURES WERE DEVIATED AND PENETRATED THE PEDICLES CORTEX MORE THAN 4 MM. THE DEVIATED SCREWS WERE REPOSITIONED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861451 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention