BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22751655 · Received August 8, 2025

    Report

    Report Number
    3004785967-2025-00547
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    January 22, 2024
    Report Date
    August 8, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E0106: CSF LEAK E0144: DURAL TEAR E0505: SUBDURAL HEMATOMA E2330: ABDOMINAL PAIN E2401: PULMONARY EMBOLISM, INTRAABDOMINAL LYMPHOCELE G2: THIS EVENT OCCURRED IN (B)(6), 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: EUROPEAN SPINE JOURNAL (2024) 33:1930¿1940 HTTPS://DOI.ORG/10.1007/S00586-023-08121-5 SUMMARY: PURPOSE: TO DESCRIBE THE TECHNIQUE AND REVIEW THE ONCOLOGICAL AND SURGICAL RESULTS OF THE EN BLOC RESECTION ASSISTED BY RETROPERITONEAL LAPAROSCOPY IN A SINGLE PRONE POSITION FOR TUMORS IN THE THORACOLUMBAR REGION. METHODS: MONOCENTRIC RETROSPECTIVE CASE STUDY. PROCEDURE WAS PERFORMED IN A SINGLE PRONE POSITION BY A DUAL TEAM OF SPINE AND THORACOVASCULAR SURGEONS. AN ENDOSCOPIC BALLOON WAS INFLATED IN THE RIGHT RETROPERITONEAL CAVITY. A PLAN WAS DEVELOPED BETWEEN THE ANTERIOR SPINE AND VENA CAVA AS WELL AS ABDOMINAL AORTA WITH SEGMENTAL VESSELS LIGATION. STRUCTURES AT RISK WERE SAFELY PROTECTED UNDER ENDOSCOPY DURING HORIZONTAL OR SAGITTAL OSTEOTOMIES. RESULTS: FROM 2021, SEVEN PATIENTS AGED A MEDIAN 52-YEAR-OLD (RANGE, 34¿67) WERE INCLUDED. INVOLVED SPINAL SEGMENTS WENT FROM T11 TO L3. SURGERY WAS ABORTED IN ONE CASE DUE TO MASSIVE BLEEDING AND VENTILATING DIFFICULTIES. THERE WERE TWO PARTIAL AND FOUR TOTAL VERTEBRAL RESECTIONS. MEDIAN OPERATING DURATION AND ESTIMATED BLOOD LOSS WERE 405 MIN (RANGE, 360¿540) AND 2.1 L (RANGE, 1.2¿19), RESPECTIVELY. POSTOPERATIVE COMPLICATIONS CONSISTED OF 1 URINARY INFECTION; 1 TRANSIENT URINARY RETENTION; 1 POSTERIOR WOUND INFECTION; 1 PNEUMOTHORAX; 1 PERSISTENT PARTIAL MOTOR DEFICIT; 1 TRANSIENT CONFUSION; 1 PULMONARY EMBOLISM; 1 CSF LEAK; 1 SUBDURAL HEMATOMA; 1 RETROPERITONEAL LYMPHOCELE. ALL MARGINS WERE UNCONTAMINATED. ALL PATIENTS WERE ALIVE AND AMBULATORY AT LAST FOLLOW-UP. CONCLUSION: EARLY RESULTS SUGGEST EN BLOC RESECTION ASSISTED BY RETROPERITONEAL VIDEOSCOPY IN TUMORS FROM T11 TO L3/4 DISK SPACE IS FEASIBLE, LESS INVASIVE AND SAFE. CAREFUL SURGICAL PLANNING AND EXPERIENCE IN ENDOSCOPIC VASCULAR SURGERY ARE MANDATORY. REPORTED EVENT(S): PATIENT 5 (MALE, 64 YEARS OLD) HAD A PULMONARY EMBOLISM AT DAY 5 AND WAS ALSO DIAGNOSED WITH A SUBDURAL HEMATOMA AT DAY 8 DUE TO A CSF LEAK. THIS WAS TREATED BY OUR INTERVENTIONAL RADIOLOGIST WHO APPLIED SOME SYNTHETIC SURGICAL GLUE MIXED WITH RADIOPAQUE SOLUTION ON THE LEAKAGE UNDER CT GUIDANCE. LASTLY, AT DAY 18, HE DEVELOPED AN INTRAABDOMINAL LYMPHOCELE WHICH WAS CAUSING HIM ABDOMINAL PAIN. PATIENT WAS PUT IN LOW-FAT DIET, AND A DRAIN WAS PLACED IN THE COLLECTION UNDER CT GUIDANCE FOR 15 DAYS. THERE WAS NO SIGN OF RECURRENCE ON SEVERAL FOLLOW-UP CT SCANS. THE PATIENT HAD A PREOPERATIVE CAUDA EQUINA SYNDROME WAS ABLE TO AMBULATE UNAIDED WITH MILD MOTOR WEAKNESS AND HAD NORMAL BLADDER FUNCTION. THE PATIENT EXPERIENCED PULMONARY EMBOLISM, CEREBROSPINAL FLUID LEAK, SUBDURAL HEMATOMA, AND RETROPERITONEAL LYMPHOCELE. "WALKING FRAME" WAS NOTED WITH REGARD TO THE PATIENT'S AMBULATORY FUNCTION. AN INTRA-OPERATIVE DURAL TEAR WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227395 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 64 YR Male Hospitalization| R