BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X

    MDR report key: 7137365 · Received December 21, 2017

    Report

    Report Number
    3005075696-2017-00010
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 21, 2017
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180465
    PMA / PMN Number
    K163221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017043.

    Description of Event or Problem · 0

    DURING SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HEALTHCARE (US) ON (B)(6) 2017 MEDIAL TRAJECTORY AT L4 DUE TO SOFT TISSUE PRESSURE FROM BILATERAL RETRACTOR RESULTED IN PROLONGATION OF MORE THAN AN HOUR DUE TO THE NEED TO REVISE THE TRAJECTORY. INVESTIGATION CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND RELATED RISKS ARE WITHIN THE RISK ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916460 MAZOR X MAZOR X HAW MAZOR ROBOTICS LTD. TPL0059 NA 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention