BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22420069 · Received July 7, 2025

    Report

    Report Number
    3004785967-2025-00448
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 7, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1906: INFECTION E2401: ARTERY INJURY G2: THIS EVENT OCCURRED IN INDIA, 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

    10.1097/BSD.0000000000001841 SUMMARY: OBJECTIVE: THIS STUDY AIMS TO DESCRIBE A WORKFLOW AND CUSTOM INSTRUMENTS FOR ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING THE MAZORX STEALTH EDITION. SUMMARY OF BACKGROUND DATA: POSTERIOR CERVICAL SPINAL INSTRUMENTATION USING PEDICLE SCREWS OFFERS BIOMECHANICAL ADVANTAGES BUT CARRIES RISKS OF INJURY TO THE VERTEBRAL ARTERY AND NERVE ROOTS. FLUOROSCOPIC AND NAVIGATION AIDS EXIST, YET ROBOTIC ASSISTANCE FOR CERVICAL PEDICLE SCREW PLACEMENT LACKS A DEFINED WORKFLOW. WHILE PREVIOUS GENERATIONS OF SPINE ROBOTS HAVE BEEN USED IN PLACING PEDICLE SCREWS, THERE ARE NO PAPERS IN LITERATURE THAT DESCRIBED THE USE OF THIRD-GENERATION SPINE ROBOTS IN PLACING THEM. METHODS: TWENTY-TWO PATIENTS UNDERGOING CERVICAL PEDICLE SCREW PLACEMENT WITH CUSTOM INSTRUMENTS AND ROBOTIC ASSISTANCE WERE INCLUDED. SCREW TRAJECTORIES WERE PLANNED AND EXECUTED BY THE ROBOTIC ARM, WITH POSTOPERATIVE O-ARM SCANS ASSESSING ACCURACY. CLINICAL AND RADIOLOGIC OUTCOMES AT 3-MONTH FOLLOW-UP WERE MEASURED. RESULTS: A TOTAL OF 206 SCREWS WERE PLACED WITH A 98.1% ACCURACY RATE. FOUR SCREWS BREACHED THE PEDICLE WITHOUT RESULTING IN NERVE ROOT INJURY. AVERAGE SURGICAL TIME WAS 190 MINUTES, WITH 6 MINUTES PER SCREW INSERTION. BLOOD LOSS AVERAGED 180 ML. NOI SCORES IMPROVED FROM 42.3 TO 28.2. COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTIONS IN 2 PATIENTS, DEEP WOUND INFECTION IN I, AND I NONDOMINANT VERTEBRAL ARTERY INJURY. REPORTED EVENT(S): THIS WAS A PROSPECTIVE STUDY OF 22 CONSECUTIVE PATIENTS WHO UNDERWENT CERVICAL PEDICLE SCREW PLACEMENT USING CUSTOM INSTRUMENTS. THERE WERE 13 MALE AND 9 FEMALE PATIENTS, AND THE PATIENTS' AVERAGE AGE WAS 56 YEARS. A TOTAL OF 206 CERVICAL PEDICLE SCREWS WERE PLACED USING ROBOTIC ASSISTANCE. FOUR SCREWS (1.9%) BREACHED THE PEDICLE: 2 BREACHES WERE LATERAL, 1 WAS INFERIOR, AND 1 WAS SUPERIOR. ONE SCREW WAS REMOVED FOLLOWING LATERAL BREACH, AND ONE SCREW COULD NOT BE PLACED DUE TO SEVERELY NARROW PEDICLE. THERE WERE NO INJURIES TO THE CERVICAL NERVE ROOTS IN ANY OF THE CASES. TWO PATIENTS EXPERIENCED SUPERFICIAL WOUND INFECTIONS THAT WERE MANAGED SUCCESSFULLY WITH REGULAR DRESSINGS AND ANTIBIOTICS. ONE PATIENT DEVELOPED A DEEP WOUND INFECTION, WHICH REQUIRED WOUND EXPLORATION AND LAVAGE. ONE PATIENT SUFFERED A NONDOMINANT VERTEBRAL ARTERY INJURY, WHICH WAS MANAGED WITH INTRAOPERATIVE TAMPING OF THE SCREW HOLE WITH BONE WAX. THE PATIENT DID NOT HAVE ANY NEUROLOGICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977 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 56 YR Male Hospitalization| R