BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23660516 · Received November 26, 2025

    Report

    Report Number
    1723170-2025-03823
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    June 17, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F1204, F24: SCREW REVISION G2: THIS EVENT OCCURRED IN SWITZERLAND. SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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

    CITATION: INTERNATIONAL JOURNAL OF SPINE SURGERY, VOL. 19, NO. 4, 2025, PP. 383-391 HTTPS://DOI.ORG/10.14444/8766. SUMMARY: BACKGROUND: COMPUTERIZED NAVIGATION IMPROVES THE ACCURACY OF SPINE PROCEDURES. HOWEVER, INTRAOPERATIVE IMAGING IS PLAGUED BY IONIZING IRRADIATION AND ITS CANCER RISK. ADVANCED TECHNOLOGIES ATTEMPT TO OPTIMIZE THE RADIATION DOSE. THE GOAL OF THIS STUDY WAS TO COMPARE RADIATION EXPOSURE AND SCREW ACCURACY OF O-ARM NAVIGATION AND THE SURGIVISIO DEVICE (SD) IN PEDICLE SCREW INSERTION. METHODS: ALL PATIENTS OPERATED ON BY NAVIGATED PEDICLE SCREW INSERTION DURING A 19-MONTH PERIOD WERE PROSPECTIVELY INCLUDED IN 2 SPINE CENTERS: THE FIRST WITH THE O-ARM AND THE SECOND WITH THE SD. DEMOGRAPHIC, OPERATIVE, AND IRRADIATION DATA WERE COLLECTED. THE ACCURACY OF THE SCREW POSITIONING WAS ASSESSED USING THE HEARY AND GERTZBEIN CLASSIFICATIONS. THE EFFECTIVE DOSE IN MILLISIEVERT (MSV) WAS CALCULATED. RESULTS: ONE HUNDRED PATIENTS WERE INCLUDED, 50 PER GROUP. FIVE HUNDRED AND TWELVE SCREWS WERE INSERTED, AMONG THEM 228 IN 120 VERTEBRAE WITH THE O-AM AND 284 IN 145 VERTEBRAE WITH THE SD. SCREW ACCURACY WAS 99 .1 % WITH THE O-ARM VS 93.3% WITH THE SD (P = 0.07). OPERATIVE TIMES WERE SIMILAR, WITH 145 VS 139 MINUTES RESPECTIVELY, P = 0.68. THE EFFECTIVE DOSE WAS SIGNIFICANTLY HIGHER IN THE O-ARM GROUP, WITH 5.43 VS 2.70 MSV WITH THE SD (P <(><<)> 0.01). THE EFFECTIVE DOSE RELATED TO 2-DIMENSIONAL IMAGING WAS SIGNIFICANTLY LOWER IN THE O-ARM GROUP THAN IN THE SD GROUP, WITH 0.26 VS 1.16 MSV, RESPECTIVELY, P <(><<)> 0.01, RELATED TO A SHORTER IMAGING DURATION (4 VS 109 SECONDS RESPECTIVELY, P <(><<)> 0.01). CONCLUSIONS: ACCURACY OF PEDICLE SCREWS WAS HIGHER WITH THE O-ARM THAN WITH THE SURGIVISIO, BUT THE LATTER SHOWED LESS RADIATION EXPOSURE. DESPITE PROMISING RESULTS, IMPROVEMENTS IN TECHNOLOGY SHOULD BE PURSUED FOR ERGONOMICS AND SURGICAL SAFETY. LEVEL OF EVIDENCE: 4. REPORTED EVENT(S): THIS EVENT REVIEWED THE CASES OF 50 PATIENTS (20 MEN, 30 WOMEN). THE AVERAGE AGE OF THE PATIENTS WAS 71 YEARS. IN THE O-ARM GROUP, 38 SCREWS WERE PLACED IN THE THORACIC AND 190 IN THE LUMBAR SPINE. FOR THE THORACIC SPINE, ACCORDING TO THE HEARY CLASSIFICATION, 36 WERE GRADE I, 1 GRADE II, 0 GRADE III, AND 1 GRADE N; 97.4% WERE RATED AS ACCEPTABLE AND 2.6% AS POOR. FOR THE LUMBAR SPINE, ACCORDING TO THE GERTZBEIN CLASSIFICATION, 179 WERE GRADE A, 10 GRADE B, 1 GRADE C, AND O GRADES D AND E; 99 .1 % WERE RATED AS ACCEPTABLE AND 0.9% AS POOR. FIVE SCREWS WERE REMOVED INTRAOPERATIVELY BECAUSE OF POOR BONE PURCHASE. NO SCREW WAS POSTOPERATIVELY REVISED IN EITHER GROUP, CONSIDERING THE UNCOMPROMISED STABILITY OF THE INSTRUMENTATION AND THE ABSENCE OF POSTOPERATIVE NEUROLOGICAL COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO ADVERSE EVENT RELATED TO THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148180 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention