BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X

    MDR report key: 6992151 · Received October 31, 2017

    Report

    Report Number
    3005075696-2017-00005
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 1, 2017
    Report Date
    January 3, 2018
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180465
    PMA / PMN Number
    K163221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON (B)(6) 2017, FROM (B)(6) DESCRIBING A SITUATION IN WHICH SCREWS CONNECTING THE PLATFORM OF THE SURGICAL ARM TO THE PATIENT CONNECTION PLATFORM (BONE MOUNT BRIDGE) WERE LOOSE. THIS WAS NOTICED PRIOR TO THE START OF THE CASE AND THE SCREWS WERE TIGHTENED BEFORE THE OPERATION BEGAN. THE SURGERY WAS PERFORMED AS INTENDED AND ALL TRAJECTORIES WERE FOUND TO BE ACCURATE. THIS EVENT DID NOT RESULT IN ANY HARM TO THE PATIENT. WHILE THE INVESTIGATION IS NOT COMPLETE, THIS EVENT IS REPORTED DUE TO THE POTENTIAL TO CONTRIBUTE TO A PATIENT HARM. NOTE: WHEN REQUESTING ADDITIONAL INFORMATION FOR THIS EVENT, THE PHYSICIAN STATED THAT HE SUSPECTS THAT THE SCREWS WERE UNTIGHTENED DURING A PREVIOUS CASE ON (B)(4) WITH THE SAME SYSTEM (SEE MDR REPORT REFERENCE NUMBER 3005075696-2017-00005). THE PHYSICIAN STATED THAT PATIENT "IS NOT FEELING WELL, AND SHOWING LOWER SIGNALS TO HER FEET". A CT WAS PERFORMED AND THE SURGEON COMMUNICATED AFTERWARDS THAT SOME OF THE UPPER THORACIC SCREWS LOOKED AS MISPLACED MEDIALLY BUT HER CONDITION IS UNRELATED TO THE SCREWS.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON OCT 1, 2017, FROM (B)(6) MEDICAL CENTER ((B)(6)) DESCRIBING A SITUATION IN WHICH SCREWS CONNECTING THE PLATFORM OF THE SURGICAL ARM TO THE PATIENT CONNECTION PLATFORM (BONE MOUNT BRIDGE) WERE LOOSE. THIS WAS NOTICED PRIOR TO THE START OF THE CASE AND THE SCREWS WERE TIGHTENED BEFORE THE OPERATION BEGAN. THE SURGERY WAS PERFORMED AS INTENDED AND ALL TRAJECTORIES WERE FOUND TO BE ACCURATE. THIS EVENT DID NOT RESULT IN ANY HARM TO THE PATIENT. THIS EVENT WAS INITIALLY REPORTED TO THE FDA ON 31 OCT. 2017, DUE TO THE POTENTIAL TO CONTRIBUTE TO A PATIENT HARM. NOTE: WHEN REQUESTING ADDITIONAL INFORMATION FOR THIS EVENT, THE PHYSICIAN STATED THAT HE SUSPECTS THAT THE SCREWS WERE UNTIGHTENED DURING A PREVIOUS CASE ON (B)(6) WITH THE SAME SYSTEM (SEE MDR REPORT REFERENCE NUMBER 3005075696-2017-00006 AND FOLLOW UP REPORT 3005075696-2017-00006-001, INTERNAL IDENTIFICATION NUMBER: (B)(4)). THE PHYSICIAN STATED THAT PATIENT "IS NOT FEELING WELL, AND SHOWING LOWER SIGNALS TO HER FEET". A CT WAS PERFORMED AND THE SURGEON COMMUNICATED AFTERWARDS THAT SOME OF THE UPPER THORACIC SCREWS LOOKED AS MISPLACED MEDIALLY BUT HER CONDITION IS UNRELATED TO THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769984 MAZOR X STEREOTACTIC INSTRUMENT HAW MAZOR ROBOTICS LTD. TPL0059 NA 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention