BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 23697732 · Received December 2, 2025

    Report

    Report Number
    3004785967-2025-00770
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 2, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F1904: SCREW REVISION F26: NO PATIENT IMPACT REPORTED G2: THIS EVENT OCCURRED IN BELGIUM, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE 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.

    Description of Event or Problem · 0

    CITATION: EUROPEAN SPINE JOURNAL HTTPS:/ /DOI.ORG/10.1007 /SO0S86-025-09568-4. SUMMARY: PURPOSE SPINAL ROBOTIC GUIDANCE PLATFORMS, WHICH RELY ON COMPUTED TOMOGRAPHY (CT) OR CONE BEAM CT (CBCT)-BASED NAVIGATION, ENABLE PRECISE PREOPERATIVE PLANNING AND INTRAOPERATIVE PLACEMENT OF PEDICLE SCREWS. HOWEVER, THEY ALSO RESULT IN SIGNIFICANT RADIATION EXPOSURE TO BOTH PATIENTS AND CLINICAL STAFF. A RECENTLY FDA- AND CE-APPROVED HIGH-RESOLUTION SYNTHETIC COMPUTED TOMOGRAPHY (SCT) TECHNOLOGY ALLOWS THE GENERATION OF CT-EQUIVALENT IMAGES FROM MAGNETIC RESONANCE IMAGING (MRI) DATA, POTENTIALLY REDUCING RADIATION EXPOSURE. AIM: TO ASSESS THE FEASIBILITY OF USING MRI-DERIVED SCT IMAGES FOR PEDICLE SCREW PLANNING AND ROBOTIC NAVIGATION, AND TO COMPARE PATIENT RADIATION DOSES BETWEEN STANDARD CTBASED AND SCT-BASED WORKFLOWS. METHODS: TWELVE PATIENTS SCHEDULED FOR THORACOLUMBAR PEDICLE SCREW FIXATION UNDERWENT 3T MRI WITH ADDITIONAL TL-WEIGHTED 3D DUAL-ECHO GRADIENT-ECHO (GRE) SEQUENCES. THESE GRE DATASETS WERE CONVERTED INTO SCT IMAGES USING BONEMRI® VL.8 (MRIGUIDANCE B.V.) AND IMPORTED INTO THE MAZOR¿ ROBOTIC GUIDANCE SYSTEM FOR PREOPERATIVE PLANNING, SCT-TO-FLUOROSCOPY FUSION, AND INTRAOPERATIVE NAVIGATION. RADIATION DOSES WERE ESTIMATED USING MONTE CARLO-BASED NCICT AND NCIRF DOSIMETRY MODELS, AND COMPARED TO THOSE FROM CONVENTIONAL CT-BASED WORKFLOWS. RESULTS: SCT IMAGES WERE VISUALLY COMPARABLE TO CONVENTIONAL CT AND FULLY COMPATIBLE WITH THE ROBOTIC NAVIGATION PLATFORM FOR BOTH PLANNING AND EXECUTION. REPLACING CT WITH SCT REDUCED PATIENT RADIATION EXPOSURE BY 98%, WITH RESIDUAL DOSE PRIMARILY RESULTING FROM INTRAOPERATIVE FLUOROSCOPY USED FOR IMAGE F USION AND VERIFICATION. CONCLUSION: MRI-DERIVED SCT OFFERS A RADIATION-FREE ALTERNATIVE TO CONVENTIONAL CT FOR SPINAL ROBOTIC GUIDANCE, ENABLING PEDICLE SCREW PLANNING AND NAVIGATION WHILE ELIMINATING CT-ASSOCIATED RADIATION EXPOSURE. REPORTED EVENT(S): TWELVE PATIENTS UNDERWENT A THORACOLUMBAR PEDICLE SCREW FIXATION WITH SCT. THE MAJORITY OF THE PATIENTS WERE FEMALE (58.3%), MEAN AGE WAS 55 +/- 19 YEARS. DURING A POST-OPERATIVE FOLLOW UP ONE L3 SCREW WAS REVISED DUE TO A MEDIAL BREACH. THIS BREACH WAS CONSIDERED A GRADE II ACCORDING TO THE HEARY CLASSIFICATION. ADDITIONALLY, IT WAS NOTED THAT FOR AN S1 SCREW PLACEMENT, IT WAS NOT FEASIBLE TO PERFORM WITH THE GUIDANCE SYSTEM DUE TO THE STEEP ANGLE AND POTENTIAL COLLISION WITH THE L5 SCREW HEADS. THE S1 AND ILIUM SCREWS WERE PLACED USING FLUOROSCOPY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810773 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention