BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9273409 · Received November 4, 2019

    Report

    Report Number
    1723170-2019-05463
    Event Type
    Death
    Date Received
    November 4, 2019
    Date of Event
    April 10, 2018
    Report Date
    November 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DATE OF EXPIRATION WAS NOT PROVIDED. DATE OF EVENT USED. EVENT DATE IS THE ACCEPTED DATE OF THE ARTICLE FOR PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, 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: UNK_OARM_SYS, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: MOURAD OULD-SLIMANE, FRANC¸OIS-XAVIER FERRACCI, SÉBASTIEN LE PAPE, ALEXIS PEREZ, PAUL MICHELIN, RÉMI GAUTHÉ. POSTERIOR C1C2 HARMS FUSION WITH 3D SURGICAL NAVIGATION. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 104(2018) 585-588. ABSTRACT: SEVERAL TYPES OF ATLANTOAXIAL INSTABILITY CAN JUSTIFY SURGICAL FIXATION. THE INSTRUMENTED FUSION PROCEDURE DESCRIBED BY HARMS WITH SCREW FIXATION OF THE C1 LATERAL MASSES AND C2 PEDICLES IS A DEMANDING TECHNIQUE THAT PROVIDES LASTING STABILIZATION. HOWEVER, IT HAS BEEN ASSOCIATED WITH NERVE AND VASCULAR COMPLICATIONS DUE TO THE LOCAL ANATOMICAL CONFIGURATION. SURGICAL NAVIGATION SYSTEMS CAN HELP IMPROVE THE PROCEDURE¿S ACCURACY. WE DESCRIBE A SERIES OF 11 CASES OF C1C2 HARMS FUSION PERFORMED WITH SURGICAL NAVIGATION AND INTRAOPERATIVE 3D IMAGING CHECKS. ALL PROCEDURES WERE CARRIED OUT COMPLETELY WITH SATISFACTORY IMPLANT PLACEMENT. THERE WERE NO ADVERSE EVENTS RELATED TO THE PROCEDURE DURING THE PERI-OPERATIVE PERIOD. NO CORTICAL BREACH WAS DETECTED USING CONE-BEAM CT AT THE END OF THE PROCEDURE. THE TECHNICAL CHALLENGES AND RISKS ASSOCIATED WITH C1C2 HARMS FUSION HAVE LED TO THE USE OF 3D INTRAOPERATIVE IMAGING SYSTEMS, WHEN AVAILABLE. REPORTED EVENTS: ONE PATIENT, WHO HAD A C2 LYCTIC LESION OF PRIMARY ORL ORIGIN, EXPIRED ON THE SECOND DAY POST-OPERATIVE FROM A MASSIVE PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066679 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death