BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 6927726 · Received October 7, 2017

    Report

    Report Number
    3005075696-2017-00003
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    April 21, 2017
    Report Date
    October 7, 2017
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180267
    PMA / PMN Number
    K120812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT ALLEGE ANY FAILURE OF MALFUNCTION OF THE DEVICE AND NO MALFUNCTION WAS IDENTIFIED (DURING INVESTIGATION). WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE USING THE RENAISSANCE SYSTEM AT (B)(6) HOSPITAL, L1 RIGHT WAS DRILLED PERCUTANEOUSLY AND WHILE INSERTING THE PEDICLE MARKER PATIENT JUMPED. IMMEDIATELY AFTER NEURO-MONITORING INFORMED THAT THE PATIENTS RIGHT LEG SIGNALS WERE DIMINISHING. SURGEONS EXPOSED THE ANATOMY AND FOUND A CSF LEAK IN THE L1 RIGHT LEVEL. NOTE: DURING SURGERY, IT WAS NOTED THAT THE RIGHT PEDICLE ANATOMY SEEMS TO BE VERY THIN. IN ADDITION, THE SCREW WAS PLANNED MEDIALLY THROUGH A VERY HYPOPLASTIC PEDICLE. UPDATE FROM 14 MAY, 2017: PURSUANT TO DISCUSSION WITH THE SURGEON, HE HAS INFORMED THAT THE PATIENT HAS IMPROVED CLINICALLY, HOWEVER, SHE IS SUFFERING FROM NEUROLOGICAL DEFICIT AND HE SUSPECTS IT WILL REMAIN PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707277 RENAISSANCE SYSTEM STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD. TPL0038 07290109180267

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability