BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 8313531 · Received February 6, 2019

    Report

    Report Number
    1723170-2019-00575
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    June 18, 2018
    Report Date
    March 7, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510K NOT PROVIDED AS CONFIRMATION OF SYSTEM MODEL HAS NOT BEEN PROVIDED. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE AVERAGE PATIENT MEAN BODY MASS INDEX WAS 24.52 KG/M2. ADDITIONAL INFORMATION: CORRECTION: SCREWS WERE POORLY PLACED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION WORLD NEUROSURG. (2018) 118:E175-E184.HTTPS://DOI.ORG/10.1016/J.WNEU.2018.06.148 - OBJECTIVE: PEDICLE SCREW PLACEMENT REMAINS CHALLENGING. THE PRESENT STUDY FOCUSES ON THE COMPARISON BETWEEN 2 INTRAOPERATIVE-BASED NEURONAVIGATION SYSTEMS (O-ARM AND AIRO) DURING THORACOLUMBAR SCREW INSTRUMENTATION. - METHODS: THIS IS A PROSPECTIVE, COMPARATIVE, NONRANDOMIZED STUDY CONDUCTED IN 2 FRENCH ACADEMIC CENTERS. THE O-ARM WAS USED AT THE UNIVERSITY HOSPITAL OF BORDEAUX, WHEREAS THE AIRO WAS USED AT THE UNIVERSITY HOSPITAL OF MARSEILLE. ROUTINE COMPUTED TOMOGRAPHY WAS PERFORMED ON POSTOPERATIVE DAY 2 TO EVALUATE PEDICLE SCREW PLACEMENT. MEASURES OF RADIATION EXPOSURE WERE EXTRACTED DIRECTLY FROM REPORTS PROVIDED BY EACH SYSTEM. THE EFFECTIVE DOSE WAS CALCULATED. - RESULTS: OVERALL, 74 SCREWS WERE PLACED IN 11 PATIENTS IN THE O-ARM GROUP AND 84 IN 11 PATIENTS IN THE AIRO GROUP. IN THE FIRST GROUP, 90.8% WERE RATED AS ACCEPTABLE AND 92.2% IN THE SECOND (P > 0.05) ACCORDING TO THE HEARY AND GERTZBEIN CLASSIFICATIONS, RESPECTIVELY, FOR THORACIC AND LUMBAR SPINE. DIFFERENCES BETWEEN BOTH IMPLANTATION SYSTEMS WERE SIGNIFICANT (P 0.05) CONCERNING DOSE LENGTH PRODUCT (235 AND 1039 MGY/CM, IN O-ARM AND AIRO, RESPECTIVELY), OVERALL MEAN RADIATION DOSE RECEIVED BY 1 PATIENT (3.52 AND 15.6 MSV IN O-ARM AND AIRO, RESPECTIVELY), MEAN RADIATION DOSE PER SINGLE SCAN (2.58 AND 8.7 MSV IN OARM AND AIRO, RESPECTIVELY), MEAN EFFECTIVE DOSE PER INSTRUMENTED LEVEL (1.04 AND 3.9 MSV IN O-ARM AND AIRO, RESPECTIVELY), AND RADIATION DOSE RECEIVED BY THE PRIMARY SURGEON (0.63 AND 0 MSV IN O-ARM AND AIRO, RESPECTIVELY). -CONCLUSIONS: INTRAOPERATIVE COMPUTED TOMOGRAPHY BASED NAVIGATION IS A MAJOR INNOVATION THAT IMPROVES THE ACCURACY OF PEDICLE SCREW POSITIONING WITH ACCEPTABLE PATIENT RADIATION EXPOSURE AND REDUCED SURGICAL TEAM EXPOSURE. 19 INACCURATELY PLACED SCREWS THAT WERE NOT REVISED.

    Description of Event or Problem · 1

    9 POORLY PLACED SCREWS THAT WERE NOT REVISED ADDITIONAL INFORMATION: THE FOLLOWING SERIAL NUMBERS WERE PROVIDED FROM THE SITE; (B)(4) SSA GOLD (B)(4) SSA GOLD (B)(4) SSA GOLD O1000 S/N: (B)(4) SSA GOLD FUSION (B)(4) SSA GOLD A SEARCH WAS CONDUCTED USING THE SERIAL NUMBERS PROVIDED BETWEEN 09-01-2016 AND 09-30-2017 AND THERE WAS NOT ENOUGH INFORMATION TO MATCH THESE DEVICES WITH SPECIFIC EVENTS REPORTED IN THE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103810 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR