BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 23366874 · Received October 23, 2025

    Report

    Report Number
    3004785967-2025-00672
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    SONI, A., VIDYADHARA, S., KANHANGAD, M.P., BALAMURUGAN, T. ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING A NOVEL HYBRID DILATOR TECHNIQUE: A CLINICAL SERIES OF 565 SCREWS. JOURNAL CRANIOVERTEBR JUNCTION SPINE. 2025. 16(3):301-306. DOI: 10.4103/JCVJS.JCVJS_115_25 BACKGROUND: CERVICAL PEDICLE SCREWS PROVIDE SUPERIOR BIOMECHANICAL FIXATION WITH PULLOUT STRENGTH FOUR TIMES GREATER THAN LATERAL MASS SCREWS, BUT PLACEMENT IS TECHNICALLY DEMANDING WITH TRADITIONAL MALPOSITION RATES OF 6.7%-31.6%. ROBOTIC-ASSISTED SPINE SURGERY HAS DEMONSTRATED SUCCESS IN THORACOLUMBAR APPLICATIONS, BUT CERVICAL TRANSLATION HAS BEEN HINDERED BY THE LACK OF CERVICAL-SPECIFIC I NSTRUMENTATION REQUIRING EXPENSIVE CUSTOM INSTRUMENTS. METHODS: WE DEVELOPED A HYBRID TECHNIQUE COMBINING ROBOTIC GUIDANCE WITH STANDARD CERVICAL INSTRUMENTATION USING MINIMALLY INVASIVE SURGERY DILATORS AS AN INTERFACE. SIXTY-FIVE CONSECUTIVE PATIENTS UNDERWENT ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT WITH 565 SCREWS ACROSS C2-C7 LEVELS USING MAZORX STEALTH ROBOTIC SYSTEM WITH O-ARM NAVIGATION. ACCURACY WAS ASSESSED USING GERTZBEIN-ROBBINS AND NEO CLASSIFICATION SYSTEMS WITH 3-6-MONTH FOLLOW-UP FOR COMPLICATIONS. RESULTS: THE TECHNIQUE ACHIEVED 98.76% CLINICALLY ACCEPTABLE ACCURACY (GERTZBEIN-ROBBINS GRADE A + B) WITH 1.24% BREACH RATE. PERFECT PLACEMENT (GRADE A) OCCURRED IN 95.22% OF SCREWS. VERTEBRAL ARTERY PROTECTION WAS EXCELLENT WITH 99.65% SHOWING NO FORAMEN BREACH. MAJOR COMPLICATIONS OCCURRED IN 1.5% OF PATIENTS (SINGLE VERTEBRAL ARTERY INJURY), WITH 7.7% EXPERIENCING TRANSIENTC5 WEAKNESS THAT RESOLVED COMPLETELY. NO PATIENTS REQUIRED REVISION SURGERY. CONCLUSIONS: THIS HYBRID TECHNIQUE ADDRESSES INSTRUMENT COMPATIBILITY BARRIERS IN ROBOTIC CERVICAL SPINE SURGERY BY ELIMINATING DEPENDENCE ON CUSTOM INSTRUMENTS WHILE MAINTAINING ROBOTIC ACCURACY. THE TECHNIQUE DEMONSTRATES SUPERIOR OUTCOMES COMPARED TO TRADITIONAL APPROACHES AND FACILITATES BROADER ROBOTIC CERVICAL SURGERY ADOPTION. MULTI-CENTER VALIDATION STUDIES ARE NEEDED TO ESTABLISH THE GENERALIZABILITY. REPORTED EVENTS: 20 SCREWS SHOWED MINOR CORTICAL CONTACT WITHOUT PENETRATION 7 SCREWS DEMONSTRATED CORTICAL BREACHED 2 SCREWS DEMONSTRATED FORAMEN BREACH 2MM 1 VERTEBRAL ARTERY INJURY IN A NONDOMINANT VESSEL MINOR COMPLICATION INCLUDED TRANSIENT C5 NERVE WEAKNESS IN 5 PATIENTS SUPERFICIAL WOUND INFECTION IN 4 PATIENTS 1 PATIENT TREATED WITH OUTPATIENT DEBRIDEMENT AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727599 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 53 YR Male Required Intervention