BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 8575539 · Received May 2, 2019

    Report

    Report Number
    3004785967-2019-00823
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 2, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: THE PROVIDED AGE IS THE MEAN AGE OF THE 49 PATIENTS THAT UNDERWENT 3D CT-GUIDED NAVIGATION SURGERIES. SEX: 48.9% OF THE PATIENTS WERE FEMALE. WEIGHT: THE AVERAGE PATIENT WEIGHT PROVIDED WAS 32.1KG/M2. DATE OF EVENT: EVENT DATE IS APPROXIMATED AS THE SURGERIES OCCURRED BETWEEN (B)(6) 2015 AND (B)(6) 2016. MODEL #, SERIAL #, UDI #: DEVICE MODEL NUMBER, AND SERIAL NUMBER ARE UNAVAILABLE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. MANUFACTURE DATE: DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OBJECTIVE: TO STUDY THE DIFFERENCES BETWEEN ROBOT-GUIDED (MAZOR X, MAZOR ROBOTICS LTD., CAESAREA, ISRAEL) AND 3-DIMENSIONAL (3D) COMPUTED TOMOGRAPHY (CT) NAVIGATION (O-ARM SURGICAL IMAGING SYSTEM, MEDTRONIC, MINNEAPOLIS, MINNESOTA, USA) FOR THE INSERTION OF PEDICLE SCREWS. METHODS: WE REVIEWED THE CHARTS OF 50 PATIENTS WHO UNDERWENT ROBOT-GUIDED PEDICLE SCREW INSERTION (BETWEEN MAY 2017 AND OCTOBER 2017), AND 49 PATIENTS WHO UNDERWENT 3D-CT NAVIGATION PEDICLE SCREW INSERTION (BETWEEN SEPTEMBER 2015 AND AUGUST 2016). VARIABLES INCLUDED WERE AGE, SEX, BODY MASS INDEX, BLOOD LOSS, LENGTH OF STAY, LUMBAR LEVEL(S), OPERATION TIME, FLUOROSCOPY TIME, RADIATION DOSE, ACCURACY, AND TIME-PER-SCREW PLACEMENT. RESULTS: MEAN AGES WERE 59.3 YEARS IN THE ROBOTIC GROUP AND 58.2 YEARS IN THE 3D-CT NAVIGATION GROUP. MEAN WAS 30.7 KG/M2 IN THE ROBOTIC GROUP AND 32.1 KG/M2 IN THE 3D-CT NAVIGATION GROUP. MEAN TIME-PER-SCREW PLACEMENT WAS 3.7 MINUTES FOR THE ROBOTIC GROUP AND 6.8 MINUTES FOR THE 3D-CT NAVIGATION GROUP, P < 0.001. IN THE ROBOTIC GROUP, 189 OF 190 SCREWS WERE PLACED WITH RAVI GRADE I ACCURACY, AND 1 WAS GRADE II. IN THE 3D-CT NAVIGATION GROUP, 157 OF 165 SCREWS WERE RAVI GRADE I, AND 8 WERE GRADE II (P [ 0.11). FLUOROSCOPY TIME (P < 0.001), TIME-PER-SCREW PLACEMENT (P < 0.001), AND LENGTH OF STAY (P < 0.001) WERE SIGNIFICANTLY LOWER IN THE ROBOTIC GROUP. CONCLUSIONS: BOTH TECHNOLOGIES ARE SAFE AND ACCURATE. ROBOTIC TECHNOLOGY EXPOSED PATIENTS TO LESS FLUOROSCOPY TIME, DECREASED TIME-PER-SCREW PLACEMENT AND SHORTER HOSPITAL STAY THAN 3D-CT NAVIGATION. FURTHER STUDIES ARE WARRANTED TO VERIFY OUR RESULTS. REPORTED EVENTS OF THE 165 INSERTED PEDICLE SCREWS, 157 (95.1%) WERE RAVI GRADE I AND 8 (4.9%) WERE RAVI GRADE II, WHICH IS CONSIDERED ACCEPTABLE (I.E., NO NEED TO REMOVE AND REPLACE THE PEDICLE SCREW). OF THE 8 SCREWS THAT WERE GRADE II, 7 WERE LATERALLY DEVIATED AND 1 WAS MEDIALLY DEVIATED AND REQUIRED REVISION INTRAOPERATIVELY; ALL DEVIATIONS WERE <2 MM. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE IMAGING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365689 MEDTRONIC NAVIGATION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other