BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 23704302 · Received December 3, 2025

    Report

    Report Number
    3004785967-2025-00771
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    July 3, 2025
    Report Date
    January 27, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A1-5) SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G3) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS UNAVAILABLE. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B5. 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: YAMADA, T., YAMATO, Y., HASEGAWA, T., YOSHIDA, G., BANNO, T., ARIMA, H., OE, S., IDE, K., KUROSU, K., MATSUYAMA, Y. (2025). CONCAVE SIDE OF PROXIMAL THORACIC ZONE VULNERABLE TO PEDICLE SCREW PERFORATION IN ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY: COMPARATIVE ANALYSIS OF PRE- AND INTRAOPERATIVE COMPUTED TOMOGRAPHY NAVIGATION. JOURNAL OF CLINICAL MEDICINE, 14(13), 4729. HTTPS://DOI.ORG/10.3390/JCM14134729 ABSTRACT BACKGROUND: THE AIM OF THIS STUDY WAS TO ASSESS PEDICLE SCREW (PS) ACCURACY AND IDENTIFY PERFORATION PATTERNS USING COMPUTED TOMOGRAPHY (CT) NAVIGATION IN ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS) SURGERY. METHODS: A TOTAL OF 107 AIS PATIENTS WERE RETROSPECTIVELY REVIEWED. PREOPERATIVE CT NAVIGATION WAS USED IN 48 PATIENTS (853 SCREWS), AND INTRAOPERATIVE CT WITH A SECOND 3D SCAN WAS USED IN 59 PATIENTS (1059 SCREWS). POSTOPERATIVE CT IMAGES WERE ANALYZED USING THE RAMPERSAUD GRADING SYSTEM. RESULTS: OVERALL PS ACCURACY (GRADE A + B) WAS SIGNIFICANTLY HIGHER IN THE INTRAOPERATIVE CT GROUP THAN THE PREOPERATIVE GROUP (97% VS. 95%, P = 0.008). IN LENKE TYPE 1 CASES, ACCURACY WAS ALSO HIGHER IN THE INTRAOPERATIVE GROUP (97.8% VS. 95.1%, P = 0.014). GRADE D PERFORATIONS WERE MOST FREQUENT ON THE CONCAVE SIDE OF THE PROXIMAL THORACIC (PT) ZONE IN BOTH GROUPS. TEN SCREWS WERE RE-INSERTED DURING SURGERY IN THE INTRAOPERATIVE GROUP BASED ON FINDINGS FROM THE SECOND 3D SCAN. CONCLUSIONS: THE CONCAVE PT ZONE IS A COMMON SITE FOR PS MISPLACEMENT. INTRAOPERATIVE CT NAVIGATION WITH A SECOND 3D SCAN ENHANCES PS ACCURACY COMPARED WITH PREOPERATIVE CT NAVIGATION. REPORTED EVENT: 1. INTRAOPERATIVE SCREW RE-INSERTION WAS PERFORMED FOR ALL SCREWS WITH RAMPERSAUD GRADE D PERFORATIONS (>4 MM BREACH). FOR GRADE C BREACHES (2¿4 MM), RE-INSERTION WAS DETERMINED AT THE SURGEON¿S DISCRETION BASED ON INTRAOPERATIVE SAFETY CONSIDERATIONS. 2. OVERALL, THERE WERE 18 PERFORATIONS IN THE PREOPERATIVE CT GROUP VERSUS 13 PERFORATIONS IN THE INTRAOPERATIVE CT GROUP. 3. A TOTAL OF 10 PSS WERE RE-INSERTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EVENTS WERE NOT RELATED TO A MEDTRONIC DEVICE, BUT WAS DUE TO THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854102 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 NA Unknown Other