BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23002208 · Received September 9, 2025

    Report

    Report Number
    3004785967-2025-00603
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 3, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3,H6): THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS NOT A SOFTWARE ISSUE. COMPLAINT DATA ANALYSIS FOUND THE EVENT IS DUE TO A USER WORKFLOW ISSUE AS PER THE COMPLAINT DATA. VERIFIED ACCURATE IMAGING SYSTEM NAVIGATION AND PERFORMED IMAGING SYSTEM CHECKOUT. COULD NOT RECREATE THE NAVIGATION INACCURACY. UNIT WAS PROPERLY FUNCTIONING AND HAD BEEN RETURNED TO SERVICE. SOFTWARE FUNCTIONING AS DESIGNED. B01,C19,D14 CODES 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.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO E. 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

    (H3, H6): MANUFACTURING REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM, VERIFIED ACCURATE IMAGING SYSTEM NAVIGATION AND PERFORMED IMAGING SYSTEM CHECKOUT. COULD NOT RECREATE THE NAVIGATION INACCURACY. UNIT WAS PROPERLY FUNCTIONING AND HAS BEEN RETURNED TO SERVICE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: (B)(6), SERIAL/LOT #:(B)(6), 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

    IMF CODE ADDED. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A 3D SPIN, THE IMAGES COME ACROSS AS INACCURATE. THE IMAGES WERE VIEWED ON THE MOBILE VIEWING STATION (MVS) AND HAD NOT YET BEEN SENT TO THE NAVIGATION SYSTEM AND THE IMAGES FAIL TO UPLOAD DICOM. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE INACCURACY. THIS HAD OCCURRED INTRA OPERATIVELY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915042 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 - 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11."