BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 24839779 · Received April 10, 2026

    Report

    Report Number
    3004785967-2026-00178
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    December 6, 2024
    Report Date
    April 10, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN ITALY, SEE 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: HTTPS://DOI.ORG/10.3390/BRAINSCI14121228. SUMMARY: BACKGROUND: CONGENITAL CRANIOVERTEBRAL JUNCTION ANOMALIES (CCVJAS) ENCOMPASS A DIVERSE RANGE OF CONDITIONS CHARACTERIZED BY DISTORTED ANATOMY AND SIGNIFICANT VARIATION IN THE PATHWAYS OF NEUROVASCULAR STRUCTURES. THIS STUDY AIMS TO ASSESS THE SAFETY AND FEASIBILITY OF TAILORING POSTERIOR FIXATION FOR CCVJAS THROUGH INTRAOPERATIVE CT-BASED NAVIGATION. METHODS: AN IN-DEPTH RETROSPECTIVE ANALYSIS WAS CONDUCTED ON EIGHT PATIENTS DIAGNOSED WITH CCVJAS (EXCLUDING ARNOLD¿CHIARI MALFORMATION). THESE PATIENTS UNDERWENT POSTERIOR FIXATION/ARTHRODESIS FACILITATED BY INTRAOPERATIVE CT-BASED NAVIGATION. THE ANALYSIS INCLUDED AN EXAMINATION OF THE FIXATION STRATEGIES, COMPLICATION RATES, LENGTH OF STAY, POST-OPERATIVE COMPLICATIONS, AND SUCCESS OF ARTHRODESIS. ADDITIONALLY, A COMPREHENSIVE LITERATURE REVIEW WAS UNDERTAKEN TO CONTEXTUALIZE AND COMPARE OUR FINDINGS. RESULTS: PATIENTS UNDERGOING CVJ POSTERIOR FIXATION WITH INTRAOPERATIVE CT-BASED NAVIGATION EXHIBITED A FLAWLESS RECORD, DEVOID OF COMPLICATIONS RELATED TO THE DAMAGE TO NEUROVASCULAR STRUCTURES, AS WELL AS ANY INSTANCES OF SCREW MISPOSITION, PULLOUT, OR BREAKAGE (0 OUT OF 36 TOTAL SCREWS). FURTHERMORE, THE ENTIRE COHORT DEMONSTRATED A 100% ARTHRODESIS RATE. NONE OF THE PATIENTS REQUIRED TREATMENT WITH AN OCCIPITAL PLATE. CONCLUSIONS: THE INCORPORATION OF INTRAOPERATIVE CT-BASED NAVIGATION PROVES TO BE AN INVALUABLE ASSET IN EXECUTING CVJ POSTERIOR FIXATION WITHIN THE CONTEXT OF CCVJAS. THIS TECHNOLOGY FACILITATES THE CUSTOMIZATION OF POSTERIOR CONSTRUCTS, A CRUCIAL ADAPTATION REQUIRED TO NAVIGATE THE ANATOMICAL CHALLENGES POSED BY THESE ANOMALIES. THE SECURE PLACEMENT OF SCREWS INTO THE OCCIPITAL CONDYLES, MADE POSSIBLE BY NAVIGATION, HAS PROVEN HIGHLY EFFECTIVE IN ACHIEVING CVJ FIXATION, OBVIATING THE NEED FOR AN OCCIPITAL PLATE. THIS TECHNOLOGICAL LEAP REPRESENTS A SIGNIFICANT ADVANCEMENT, ENHANCING THE SAFETY, PRECISION, AND OVERALL OUTCOMES FOR PATIENTS UNDERGOING THIS SURGICAL PROCEDURE, WHILE CONCURRENTLY REDUCING THE NECESSITY FOR MORE INVASIVE AND MORBID INTERVENTIONS. REPORTED EVENT(S): IN THE IMMEDIATE POST-OPERATIVE PERIOD, ONE CASE (MALE, 78 YEARS OLD) EXPERIENCED A DORSAL CERVICOTHORACIC HEMATOMA ON THE 14TH POST-OPERATIVE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479005 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1