BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22896313 · Received August 26, 2025

    Report

    Report Number
    3004785967-2025-00576
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN JAPAN, 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: NEUROSPINE 2025;22(2):514-522. HTTPS://DOI.ORG/10.14245/NS.2550110.055 SUMMARY: OBJECTIVE: PARAVERTEBRAL FORAMEN SCREWS (PVFSS) HAVE BEEN DEVELOPED FOR BETTER PULLOUT STRENGTH THAN LATERAL MASS SCREWS DO AND LOWER THE RISK OF VERTEBRAL ARTERY AND NERVE INJURY THAN DO PEDICLE SCREWS. WHILE THE ORIGINAL METHOD INVOLVES INSERTION USING LATERAL FLUOROSCOPY, ITS RELIABILITY MAY BE LIMITED. THIS REPORT IS THE FIRST TO ASSESS THE ACCURACY OF PVFS INSERTION UNDER NAVIGATION. GIVEN THE INHERENT INACCURACIES ASSOCIATED WITH NAVIGATION SYSTEMS, THE AUTHORS PROPOSE AND EVALUATE A NOVEL STEPWISE METHOD OF INSERTING PVFSS, CALLED STEPWISE PVFS WITH A FOCUS ON ACHIEVING THE CORRECT SCREW TIP LOCATION FOR GOOD CORTICAL BONE PURCHASE. METHODS: THE AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS OF 12 PATIENTS (78 SCREWS) WHO UNDERWENT CERVICAL SPINE FIXATION WITH STEPWISE PVFS UNDER O-ARM NAVIGATION BETWEEN OCTOBER2022 AND FEBRUARY 2024. THE ACCURACY OF SCREW PLACEMENT WAS EVALUATED USING POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS. RESULTS: A TOTAL OF 78 PVFSS WERE INSERTED IN 5 MEN AND 7 WOMEN, WITH AN AVERAGE AGE OF 75 YEARS (RANGE, 52¿85 YEARS). THE MEAN FOLLOW-UP PERIOD WAS 471 DAYS (RANGE, 47¿834 DAYS). THERE WERE NO ADVERSE EVENTS RELATED TO SCREW INSERTION. POSTOPERATIVE CT SCANS REVEALED THAT 70 SCREWS (90%) WERE PLACED IN THE IDEAL POSITION. AMONG THE 8 SCREWS THAT DID NOT ACHIEVE THE IDEAL POSITION, 4 HAD LATERAL DEVIATION (LOCATED IN A LATERAL MASS), WHEREAS THE OTHER 4 WERE TOO SHORT. THERE WERE NO CASES OF SCREW LOOSENING AT THE FINAL FOLLOW-UP. CONCLUSION: THE PRESENT STUDY DEMONSTRATES THAT THE STEPWISE PVFS METHOD UNDER NAVIGATION GUIDANCE ACHIEVES HIGHER ACCURACY IN PVFS PLACEMENT COMPARED WITH CONVENTIONAL FLUOROSCOPY-GUIDED PVFS, AS REPORTED IN PREVIOUS STUDIES. REPORTED EVENT(S): THIS ARTICLE DISCUSSED THE CASES OF 5 MEN AND 7 WOMEN. THE AVERAGE PATIENT AGE WAS 75 YEARS. 78 TOTAL SCREWS WERE PLACED. THERE WERE NO ADVERSE EVENTS RELATED TO SCREW INSERTION.12 SCREWS WERE CLASSIFIED AS ¿IDEAL POSITION. 59 SCREWS WERE CATEGORIZED AS ¿SHORT-LENGTH SCREWS.¿ 4 SCREWS SHOWED LATERAL DEVIATION. 3 SCREWS COULD NOT BE EVALUATED DUE TO UNCLEAR IMAGING. A TOTAL OF 67 SCREWS WERE FURTHER INSERTED, INCLUDING 8 IDEAL SCREWS ADJUSTED TO MATCH UP THE SCREW HEADS IF EXTRA SPACE EXISTED, AND 59 SHORT-LENGTH SCREWS INSERTED TO ACHIEVE THE IDEAL POSITION. OF THE 11 SCREWS THAT WERE NOT FURTHER INSERTED, 4 WERE LEFT BECAUSE THEY WERE ALREADY IN THE IDEAL POSITION WITHOUT EXTRA SPACE, 4 WERE NOT FURTHER INSERTED DUE TO LATERAL DEVIATION, AND 3 WERE NOT CONSIDERED FOR FURTHER INSERTION DUE TO UNCLEAR IMAGING. POSTOPERATIVE CT SCANS REVEALED THAT 70 SCREWS WERE ULTIMATELY PLACED IN THE IDEAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704925 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 75 YR Female