BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23124482 · Received September 23, 2025

    Report

    Report Number
    3004785967-2025-00618
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO A AND B5 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000218, H6: THE SYSTEM WAS SERVICED IN THE FIELD AND NAVIGATION CALIBRATION WAS COMPLETED AND THE ACCURACY OF THE LEFT AND RIGHT TRACKERS WAS VERIFIED. CODES B01, C13, AND D02 APPLY. 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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT FELT NUMBNESS IN THEIR LEGS THERE WAS NO DELAY TO THE CASE. THE SITE DID A RE-SPIN OF THE IMAGING SPIN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AFTER THE SYSTEM RAN A SPIN, THE SURGEON NOTICED THAT THE IMAGES WERE MORE SUPERIOR THAN EXPECTED. THEY WERE DOING AN L2 TO L5 CASE, AND THEY FOUND THAT WHILE ON THE L3 THEY NEEDED TO DO ANOTHER SPIN. AFTER THE SPIN, THEY FOUND THAT THE SCREWS WERE ALL THE WAY THROUGH THE VERTEBRAL BODY. BOTH SPINS WERE DONE USING A PERC PIN PLACED ON THE PATIENT'S RIGHT SIDE, PSIS, USING THE 150. THE SECOND SPIN USED A Z-DRAPE. THE SURGEON ABORTED THE USE OF THE MEDTRONIC IMAGING SYSTEM AND USED A NON-MEDTRONIC IMAGING SYSTEM TO VERIFY CORRECTIONS BEING MADE WITH THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219034 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention "SEE H11...."