BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 23799505 · Received December 14, 2025

    Report

    Report Number
    3004785967-2025-00798
    Event Type
    Injury
    Date Received
    December 14, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN FRANCE, 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: HTTPS://DOI.ORG/10.1016/J.NEUCHI.2025.1017 41 SUMMARY: SURGICAL ROBOTICS REPRESENT A SIGNIFICANT ADVANCEMENT IN HEALTHCARE, ENHANCING PRECISION AND SAFETY IN OPERATIVE PROCEDURES. WHILE WIDELY USED IN NEUROSURGERY, VISCERAL SURGERY, AND UROLOGY, ITS ADOPTION IN SPINAL SURGERY REMAINS IN DEVELOPMENT. THIS STUDY REPORTS THE IMPLEMENTATION OF ROBOTIC-ASSISTED SPINE SURGERY WITHIN A NEUROSURGICAL DEPARTMENT, FOCUSING ON THE LEARNING CURVE, WORKFLOW INTEGRATION, COMPLICATIONS, AND PROSPECTS. SUCCESSFUL INTEGRATION REQUIRES A DEDICATED TECHNICAL INFRASTRUCTURE AND THOROUGH TRAINING-BOTH THEORETICAL AND PRACTICAL-FOR THE ENTIRE SURGICAL TEAM. COLLABORATION AMONG SURGEONS, PARAMEDICAL STAFF, AND BIOMEDICAL ENGINEERS IS ESSENTIAL TO OPTIMIZE OUTCOMES. WE USED A TABLE-MOUNTED ROBOTIC SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC), WITH SURGICAL PLANNING BASED ON PREOPERATIVE, SUB-MILLIMETRIC BONE-DENSITY CT SCANS TO ENSURE PERSONALIZED CARE. FROM NOVEMBER 2022 TO MAY 2023, WE INCLUDED 32 PATIENTS WITH AN AVERAGE AGE OF 58 Y/O (SD 15 (19; 87)) FOR A TOTAL OF 204 INSERTED SCREWS. DEGENERATIVE SPINE REPRESENTED THE MAIN INDICATION FOLLOWED BY TUMORAL SPINE. OPTIMAL ACCURACY FOR PEDICLE SCREW PLACEMENT WAS 97 % CORRESPONDING TO GRADE A (90.1%) AND GRADE B (6.9%) FROM GRS. THE OPERATING TIME WAS OF 186.7 MIN (SD 89.7 (45; 386)) AND THE AVERAGE FLUOROSCOPY TIME PER SCREW WAS OF 3.0 S (1.8-5.5). INSTALLATION IS A TIME-CONSUMING STEP. WE OBSERVED A TREND TOWARDS SHORTER OPERATING TIMES AS MORE CASES ARE OPERATED ON. NO REVISION SURGERY WAS NEEDED DURING THE STUDY PERIOD. ONLY 2 SUPERFICIAL SKIN INFECTIONS WERE REPORTED, WITH NO OTHER COMPLICATION. ROBOTIC SPINE SURGERY IMPROVES STANDARDIZATION, ENHANCES ACCURACY, AND PROMOTES PERSONALIZED MEDICINE, WITH POTENTIAL FOR FURTHER WORKFLOW OPTIMIZATION. REPORTED EVENT(S): A TOTAL OF 32 PATIENTS INCLUDING 14 WOMEN AND 18 MEN WITH AN AVERAGE AGE OF 58 YEARS WAS INCLUDED. A TOTAL OF 204 SCREWS WERE INSERTED. OPTIMAL ACCURACY WAS REPORTED IN 97% OF SCREWS PLACED. 3% WERE CONSIDERATE AS INACCURATE. A 19-YEAR-OLD MALE HAD DYSESTHESIA OF THE RIGHT FLANK WITH NO IMPACT ON QUALITY OF LIFE AND NO SPECIFIC COMPLAINTS. A 19-YEAR-OLD FEMALE HAD NO EARLY POSTOPERATIVE COMPLICATIONS OTHER THAN TRANSIENT PARAESTHESIA OF THE LEFT LOWER LIMB. A TRANSFUSION OF RED BLOOD CELLS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336211 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 58 YR Male Required Intervention