BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 7023542 · Received November 11, 2017

    Report

    Report Number
    3005075696-2017-00007
    Event Type
    Injury
    Date Received
    November 11, 2017
    Date of Event
    October 4, 2017
    Report Date
    November 11, 2017
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180465
    PMA / PMN Number
    K163221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER 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

    A COMPLAINT WAS RECEIVED ON (B)(6) 2017, FROM (B)(6) DESCRIBING A SITUATION IN WHICH A PROCEDURE (PERFORMED ON (B)(6) 2017) WENT WELL USING THE MAZOR X SYSTEM. THE SURGEON CONFIRMED THE ACCURACY OF PLACEMENT OF ALL THE PEDICLE SCREWS WHICH WERE PLACED WITH THE GUIDANCE OF THE MAZOR X SYSTEM WITH INTRAOPERATIVE FLUORO CONFIRMATION IMAGES. NEURO-MONITORING WAS ALSO EMPLOYED AND DID NOT INDICATE A BREACH OF THE PEDICLE. HOWEVER, THE NEXT DAY THE PATIENT COMPLAINED OF LEG/RADICULAR NERVE PAIN AND WAS TAKEN BACK TO THE HOSPITAL. THE SURGEON THEN INDICATED THAT SCREWS ON THE RIGHT SIDE WERE MEDIAL, WITH ONE OR MORE IN THE CANAL. THE SURGEON PERFORMED A REVISION AND REPOSITIONED THE SCREWS IN L3 AND L4 BY FREEHAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802748 MAZOR X SYSTEM STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD. TPL0059 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention