BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 19413771 · Received May 29, 2024

    Report

    Report Number
    3004785967-2024-00324
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 29, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    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. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    VISOCCHI, M., SIGNORELLI, F. CRANIOVERTEBRAL JUNCTION SURGICAL APPROACHES: STATE OF ART. ADVANCES AND TECHNICAL STANDARDS IN NEUROSU RGERY 50. HTTPS://DOI.ORG/10.1007/978-3-031-53578-9_10 THE CRANIOVERTEBRAL JUNCTION (CVJ) IS A COMPLEX NEUROVASCULAR TRANSITION CONDUIT BETWEEN THE CRANIUM AND THE UPPER CERVICAL SPINE CONSISTING OF THE OCCIPITAL BONE, ATLAS (C1), AXIS (C2), AND SUPPORTING LIGAMENTS. A VARIETY OF PATHOLOGIES CAN AFFECT THIS REGION, INCLUDING CONGENITAL MALFORMATIONS, TUMORS, INFLAMMATORY CONDITIONS, AND TRAUMA. ALTHOUGH PATHOLOGIES AFFECTING THE CRANIOVERTEBRAL JUNCTION (CVJ) ARE RELATIVELY RARE, THEIR CONSEQUENCES CAN BE VERY SERIOUS AND LIFE-THREATENING, THUS DESERVING GREAT CONSIDERATION AMONG BOTH BRAIN AND SPINE SURGEONS. REPORTABLE EVENTS: C1 LATERAL MASSES AND C2 ISTHMI NAVIGATION WERE UNSUITABLE DUE TO THE ANGLED PROJECTION UNFITTING WITH THE NEURONAVIGATION OPTICAL SYSTEM. SCREW PLACEMENT WAS SUBOPTIMAL AT THE IMMEDIATE POSTOPERATIVE RADIOLOGICAL ASSESSMENT. IN THIS CASE, THE HARDWARE DISPLACEMENT OCCUR RED 2 MONTHS LATER AND REOPERATION WAS NECESSARY. IN ONE CASE, DURING ENDOSCOPIC EXPLORATION OF THE INFERIOR CORRIDOR, TEARING OF THE EMERGING ROOTS OF THE 11TH CRANIAL NERVE OCCURRED. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884724 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention