BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 7704414 · Received July 19, 2018

    Report

    Report Number
    3005075696-2018-00019
    Event Type
    Death
    Date Received
    July 19, 2018
    Date of Event
    June 19, 2018
    Report Date
    July 18, 2018
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180267
    PMA / PMN Number
    K120812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 AT (B)(6) PRIVATE HOSPITAL ((B)(6)) A (B)(6) FEMALE PATIENT WAS OPERATED ON HER L4 VERTEBRA. THE SURGICAL PLAN WAS TO PLACE BILATERAL PEDICLE SCREWS (45 X 6.5 MM, EVEREST XT, K2M) IN L4 AS AN EXTENSION OF A PREVIOUS L5-S1 FUSION SURGERY. AS THE LEFT L4 PEDICLE SCREW WAS BEING IMPLANTED, THE ANAESTHETIST MADE THE SURGEON AWARE THAT THERE WAS A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE. A LATERAL X-RAY IMAGE WAS TAKEN OF THE SCREWS, WHICH SHOWED THAT THE FRONT OF THE RIGHT L4 SCREW WAS PROTRUDING OUT OF THE FRONT OF THE L4 VERTEBRAL BODY. AT THIS POINT, THE ROBOTIC PLATFORM AND THE RIGHT L4 PEDICLE SCREW WAS IMMEDIATELY REMOVED. THE LEFT L4 PEDICLE SCREW REMAINED IN SITU. THE PATIENT WAS CLOSED UP POSTERIORLY AND HANDED OVER TO THE VASCULAR SURGEONS. THE PATIENT PASSED AWAY LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546163 RENAISSANCE SYSTEM STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD. TPL0038 07290109180267

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death