BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22570560 · Received July 22, 2025

    Report

    Report Number
    3004785967-2025-00505
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 23, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E2401: HEMORRHAGIC SHOCK, NOSEBLEED E0505: CLOT E0506: HEMORRHAGE E1801: TUMOR E2015: LESION E0514: THROMBUS G2: THIS EVENT OCCURRED IN FRANCE, 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.

    Additional Manufacturer Narrative · 0

    H2, E1: FACILITY LOCATION UPDATED. EVENT OCCURRED IN LEBANON, NOT FRANCE. 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: HTTPS://DOI.ORG/L0.1016/JJVSCIT.2025.101845 SUMMARY: WE REPORT THE CASE OF A 61-YEAR-OLD FEMALE WITH METASTATIC RECTAL ADENOCARCINOMA WHO UNDERWENT SURGICAL FIXATION AND LAMINECTOMY FOR AN L3 VERTEBRAL COMPRESSION FRACTURE. PEDICLE SCREWS WERE AUGMENTED WITH CEMENT. FOLLOW-UP COMPUTED TOMOGRAPHY LATER DETECTED AN INCIDENTAL PULMONARY CEMENT EMBOLISM IN THE RIGHT PULMONARY ARTERY. THE PATIENT REMAINED ASYMPTOMATIC AND WAS MANAGED WITH ANTICOAGULATION THERAPY. SUBSEQUENT GASTROINTESTINAL BLEEDING REQUIRED TEMPORARY CESSATION OF ANTICOAGULATION. BUT PROPHYLACTIC ANTICOAGULATION WAS RESUMED DUE TO THE PERSISTENT EMBOLUS. AT 6-MONTH FOLLOW-UP. THE PATIENT REMAINED STABLE WITHOUT HEMORRHAGIC COMPLICATIONS. IN ASYMPTOMATIC CENTRAL PULMONARY CEMENT EMBOLISMS. ANTICOAGULATION MAY BE APPROPRIATE BUT REQUIRES CAREFUL RISK ASSESSMENT AND MULTIDISCIPLINARY MANAGEMENT TO BALANCE THE RISKS OF THROMBOSIS AND BLEEDING. (J VASE SURG CASES LNNOV TECH 2025:11:101845.) REPORTED EVENT: THE PROCEDURE WAS COMPLETED WITH THE POSTOPERATIVE FILMS SHOWING CEMENT LEAKAGE AROUND L2. ONE MONTH AFTER SURGERY, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN SHOWED DISEASE PROGRESSION AND A HYPERDENSE LESION IN THE RIGHT PULMONARY ARTERY ON NON-CONTRAST PHASE, DEMONSTRATING CEMENT EMBOLIZATION. IN ADDITION, CONTRAST PHASE SHOWED AN ASSOCIATED HYPODENSE LESION AROUND THE CEMENT EMBOLUS. SUGGESTIVE OF THROMBUS. THERE WAS NO EVIDENCE OF RIGHT VENTRICULAR STRAIN. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT RECEIVED ADJUVANT RADIOTHERAPY TARGETING THE L3 VERTEBRAL METASTASIS AND RECTAL TUMOR. WHILE ON TINZAPARIN TREATMENT, SHE DEVELOPED A LOWER GASTROINTESTINAL HEMORRHAGE, LEADING TO HEMORRHAGIC SHOCK. COLONOSCOPY REVEALED A HIGHLY ULCERATED RECTAL TUMOR WITH AN ADHERENT CLOT BUT NO ACTIVE BLEEDING. LAST PATIENT FOLLOW-UP (11 MONTHS POST-CIMENTOPLASTY), THE PATIENT DID NOT EXPERIENCE ANY THROMBOSIS RECURRENCE BUT A FEW RARE CASES OF NOSEBLEED FOLLOWING BLOWING, WHICH DID NOT REQUIRE SPECIFIC MEDICAL ADVICE (MINOR BLEEDING EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785671 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 61 YR Female Hospitalization| R