BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23524417 · Received November 11, 2025

    Report

    Report Number
    3004785967-2025-00721
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 9, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00763000132378
    PMA / PMN Number
    K200074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. PLEASE LOOK TO REG REPORT: 3005075696-2025-00373 FOR THE MAZOR COMPLAINT. 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: M021083C001, VERSION #: 4.2.1 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) THE MANUFACTURE REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM AND COMPLETED SYSTEM CHECKOUT AS PER USER MANUAL. SYSTEM PASSED ALL CHECKS, INCLUDING NAVIGATION COMPONENTS, AND HAD BEEN RETURNED FOR USE. MDR CODES: B01, C19, D14. 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) THE SOFTWARE INVESTIGATION FOUND THAT THERE WAS NO SOFTWARE ISSUE FOUND. SOFTWARE WAS FUNCTIONING AS DESIGNED. MDR CODES: B01, C19, D14. 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY WHERE THE SCREWS WERE SHIFTED. NO OTHER ADDITIONAL INFORMATION WAS REPORTED AT THE TIME OF THE CALL. ADDITIONAL INFORMATION WAS RECEIVED. DURING SERVICE, IT WAS REPORTED THAT A DAMAGED PNEUMATIC TUBING WAS FOUND. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A MIS PSIF. THERE SEEMED TO BE A GLOBAL SHIFT AS ALL LEFT SCREWS WERE MEDIAL AND ALL SCREWS ON THE RIGHT WERE LATERAL BETWEEN 3.5 TO 10MM. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A SCAN AND PLAN ON T8-L3. A SCHANZ BRIDGE WAS MOUNTED TO THE PSIS, AND A BED WAS JACKKNIFED. THE LEVELS AFFECTED WERE T9-T12. IT WAS NOTED THAT THE TARGET EXTENDER HAD A MISSING POSITIONING SCREW. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SPINAL CORD INJURY AT T11 AND T12. THERE WAS DECREASED NERVE ACTIVITY IN THE BILATERAL LOWER EXTREMITIES. THERE WAS A DELAY TO THE PROCEDURE. IT WAS NOTED THE PATIENT CAME BACK THE NEXT DAY FOR A REVISION. THE CASE WAS COMPLETED FREEHANDEDLY WITH NEW SCREWS. THE METHOD WAS NOTED TO BE AN OPEN MIDLINE LAMI [LAMINECTOMY]. THE PROCEDURE WAS FROM LEVELS T9-L3. THEY HAD PLANNED FOR T8-L4 BUT SKIPPED THE TOP AND BOTTOM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545409 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 00763000132378

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention