BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11315081 · Received February 11, 2021

    Report

    Report Number
    1723170-2021-00371
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    October 15, 2020
    Report Date
    February 11, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI70002000, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: MASSIMILIANO VISOCCHI, PIER PAOLO MATTOGNO, PASQUALINO CIAPPETTA, GIUSEPPE BARBAGALLO, FRANCESCO SIGNORELLI. COMBINED TRANSORAL EXOSCOPE AND O-ARM-ASSISTED APPROACH FOR CRANIOVERTEBRAL JUNCTION SURGERY: LIGHT AND SHADOWS IN SINGLE-CENTER EXPERIENCE WITH IMPROVING TECHNOLOGIES. JOURNAL OF CRANIOVERTEBRAL JUNCTION AND SPINE 2020;11:293-9. ABSTRACT: BACKGROUND: THE INTRODUCTION OF RECENT INNOVATIONS IN THE FIELD OF INTRAOPERATIVE IMAGING AND NEURONAVIGATION, SUCH AS OARM STEALTH STATION, ALLOWS TO OBTAIN CRUCIAL INTRAOPERATIVE DATA BY PERFORMING SAFER AND CONTROLLED SURGICAL PROCEDURES. AS PART OF THE IMPROVEMENT OF SURGICAL VISUAL MAGNIFICATION AND WIDE EXPANSION OF SURGICAL CORRIDORS, THE 3D-4K EXOSCOPE (EX) REPRESENTS NOWADAYS AN INTERESTING AND USEFUL TOOL. TRANSORAL APPROACH (TOA) REPRESENTS THE HISTORICAL GOLD STANDARD DIRECT MICROSURGICAL ROUTE TO VENTRAL CRANIOVERTEBRAL JUNCTION (CVJ). METHODS: WE HEREIN REPORT A PRELIMINARY EXPERIENCE ON 6 CASES OF 33 PATIENTS OPERATED BY TOA CONCERNING THE SIMULTANEOUS APPLICATION OF OARM WITH STEALTH NAVIGATION SYSTEM (MEDTRONIC, MEMPHIS, TN) AND IMAGING SYSTEM ALONG WITH THE 3D-4K EXS IN TOA FOR THE TREATMENT OF CVJ PATHOLOGIES. RESULTS: NEITHER INTRAOPERATIVE NEUROPHYSIOLOGICAL CHANGES NOR POSTOPERATIVE INFECTIONS OCCURRED, BUT A NEUROLOGICAL IMPROVEMENT WAS EVIDENT IN ALL THE PATIENTS. A COMPLETE DECOMPRESSION ALONG WITH STABLE INSTRUMENTATION AND FUSION OF THE CVJ WAS ACCOMPLISHED IN ALL CASES AT THE MAXIMUM FOLLOW-UP (MEAN: 16.8 MONTHS). CONCLUSIONS: WITH EX, THE ROLE OF SURGEON BECOMESELF-SUFFICIENT WITH A BETTER INDIVIDUAL SURGICAL FREEDOM COMPARED TO ENDOSCOPIC SURGERY AND EXCELLENT 3D VISION AND MAGNIFICATION. OARM ALLOWS AN ABSOLUTELY RELIABLE INTRAOPERATIVE SUPPORT FOR A MORE EFFECTIVE CVJ DECOMPRESSION. NEVERTHELESS, WITH OARM-ASSISTED NEURONAVIGATION, IT CAN BE DIFFICULT TO NAVIGATE C1 LATERAL MASSES AND C2 ISTHMI, AND TO CONVERT 3D INTO 2D REAL-TIME NAVIGATION, IT CAN BECOME QUITE COMPLICATE. FINALLY, THE ASSOCIATION OF EX AND OARM APPEARS MORE TIME CONSUMING COMPARED TO THE OLD FASHION ONE. REPORTED EVENT: PATIENT 4 EXPERIENCED SUB-OPTIMAL SCREW PLACEMENT AT THE IMMEDIATE POST-OPERATIVE ASSESSMENT. HARDWARE DISLODGEMENT OCCURRED 2 MONTHS LATER REQUIRING POSTERIOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213233 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention