BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 23511123 · Received November 10, 2025

    Report

    Report Number
    3004785967-2025-00716
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    September 19, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. 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

    ASPALTER, S., STROH-HOLLY, N., HÖLLMÜLLER, K., DAVACHI, A., RAUCH, P., HEISINGER, S., GRUBER, A., SENKER, W. ACCURACY OF NAVIGATED HIGH-SPEED DRILL-ASSISTED CERVICAL AND UPPER THORACIC PEDICLE SCREW PLACEMENT¿A SINGLE CENTER EXPERIENCE WITH 1112 PEDICLE SCREWS. JOURNAL OF CLINICAL MEDICINE. 2025. 14 (6597). HTTPS://DOI.ORG/10.3390/JCM14186597 BACKGROUND/OBJECTIVES: WHILE BIOMECHANICALLY SUPERIOR, CERVICAL PEDICLE SCREW PLACEMENT IS TECHNICALLY CHALLENGING, AND THEREFORE TYPICALLY PERFORMED ONLY IN CENTERS WITH THE AID OF NAVIGATION. THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE ACCURACY AND SAFETY OF NAVIGATED CERVICAL PEDICLE SCREW (CPS) PLACEMENT USING INTRAOPERATIVE IMAGING WITH A WORKFLOW USING A NAVIGATED HIGH-SPEED DRILL IN A LARGE SINGLE-CENTER COHORT. METHODS: WE CONDUCTED A RETROSPECTIVE ANALYSIS OF 205 PATIENTS UNDERGOING POSTERIOR CERVICAL OR CERVICOTHORACIC INSTRUMENTATION BETWEEN JANUARY 2018 AND JUNE 2024. ACCURACY WAS ASSESSED USING THE GERTZBEIN¿ROBBINS CLASSIFICATION, WITH GRADES 0 AND 1 CONSIDERED SAT ISFACTORY. SURGICAL WORKFLOW, INTRAOPERATIVE IMAGING, AND COMPLICATIONS WERE ANALYZED. RESULTS: A TOTAL OF 1112 PEDICLE SCREWS, INCLUDING 888 CERVICAL AND 224 UPPER THORACIC SCREWS, WERE EVALUATED. 801 WERE GRADE 0 (72.0%), 250 GRADE 1 (22.5%), 56 GRADE 2 (5.0%), AND 5 GRADE 3 (0.4%). CERVICAL SCREWS ACHIEVED SATISFACTORY PLACEMENT GRADES 0 AND 1 IN 93.1%, AND UPPER THORACIC SCREWS IN 100% (92.0% GRADE 0, 8.0% GRADE 1). GRADE 3 BREACHES OCCURRED IN C2, C3, C5, C6, AND C7, WITH ONE CASE EACH. THERE WERE NO CASES OF IMPLANT-RELATED NEUROVASCULAR INJURIES. CONCLUSIONS: THIS STUDY DEMONSTRATES HIGH SCREW ACCURACY WITH A LOW OBSERVED COMPLICATION RATE. NO REVISION SURGERIES WERE REQUIRED DUE TO SCREW MALPOSITION, BUT 7 CASES OF SCREW LOOSENING OCCURRED. HOWEVER, THE RETROSPECTIVE DESIGN AND RELIANCE ON INTRAOPERATIVE IMAGING LIMIT THE GENERALIZABILITY OF THE FINDINGS. REPORTED EVENTS: 500 WERE GRADE 1 WHICH IS A MINOR CORTICAL BREACH UP TO 2 MM 112 WERE GRADE 2 WHICH IS A CORTICAL BREACH GREATER THAN 2 MM 10 WERE GRADE 3 WHICH IS A CORTICAL BREACH GREATER THAN 4 MM 18 PATIENTS NEEDED A REVISION SURGERY. THE MOST FREQUENT CAUSE OF THIS WAS DUE TO A SCREW LOOSENING (7 PATIENTS). ONE OF THE REVISIONS FOR SCREW LOOSENING WAS ASSOCIATED WITH AN INFECTION. 6 CASES WERE DUE TO REBLEEDING, ALL CASES PRESENTED WITH NEW, TEMPORARY SENSORY OR MOTOR DYSFUNCTION POSTOPERATIVE. ALL NEUROLOGICAL DEFECTS WERE RESOLVED AFTER EVACUATION OF THE HEMATOMA. 4 CASES WERE DUE TO WOUND HEALING DISORDER. PROLONGED THERAPY WITH A VACUUM-ASSISTED CLOSURE DEVICE WAS NECESSARY FOR 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543388 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) 9732719

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention