BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23521996 · Received November 11, 2025

    Report

    Report Number
    3004785967-2025-00718
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6): THE MANUFACTURING REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM BUT COULD NOT OBTAIN INFORMATION ON WHICH SIDE OF THE IMAGING SYSTEM WAS INACCURATE. CHECKED ACCURACY: RIGHT SIDE ±0.84 MM, LEFT SIDE ±1.22 MM (SPECIFICATION ±1.25 MM). THE SITE NEEDS TO PROVIDE THE SYSTEM TO PERFORM A RECALIBRATION. THE SYSTEM CAN BE USED WITH THE RIGHT-SIDE TRACKER. RECALIBRATED THE RIGHT-SIDE TRACKER. THERE WERE DELAYS IN OBTAINING A STEALTH SYSTEM. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000218. PRODUCT ID: BI71000219. 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

    ADDITIONAL INFO: UPDATED 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.

    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 T10¿PELVIS CASE, WHILE TAKING A NAVIGATED SPIN, THE ACCURACY WAS POOR. THE CLINICAL SERVICE REPORTED TAKING FOUR ADDITIONAL SPINS, ALL OF WHICH WERE INACCURATE. THEIR OTHER IMAGING SYSTEM WAS BROUGHT IN, REGISTRATION WAS ACCURATE, AND THE CASE WAS ABLE TO CONTINUE. IT OCCURRED INTRA OPERATIVELY AND THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED "THERE WAS INACCURACY OF 10 MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525311 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male