BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23356641 · Received October 22, 2025

    Report

    Report Number
    3004785967-2025-00668
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00763000616564
    PMA / PMN Number
    K200074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M018081C001, VERSION #: 4.2.0 H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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, H6: A SOFTWARE ANALYSIS WAS INITIATED. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION/LOGS AS PER EVENT DATE. 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) ADDITIONAL INFORMATION WAS ADDED TO 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY THAT HAD OCCURRED. AN ADVERSE PATIENT EVENT OCCURRED WHEN USING THIS SYSTEM. NO INFORMATION PERTAINING TO THE EVENT HAS BEEN PROVIDED AT THIS TIME. AN ADDITIONAL SURGERY WAS NEEDED SUE TO AN ADVERSE EVENT RELATED TO THE STUDY INDEX SURGERY. THERE WAS SEVERE STENOSIS. THERE WAS INTERVERTEBRAL THORACIC DISC DISORDER WITH MYELOPATHY, THORACIC REGION. THERE WAS FUSION EXTENSION THAT OCCURRED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    THERE WAS NO REPORTED DELAY TO THE CASE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THERE WAS WORSENING PAIN AND THE PATIENT WAS RE-ADMITTED FOR EVALUATION. THE IMAGING DEMONSTRATED SIGNIFICANT DISC HERNIATIONS AT T7/8 AND 8/9 CAUSING SEVERE STENOSIS. THE DECISION WAS MADE TO EXTEND THE FUSION TO T4 WITH THORACIC DISCECTOMY FOR DECOMPRESSION. AN ADDITIONAL PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446560 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 00763000616564

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention "SEE H11....".