BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 11832387 · Received May 17, 2021

    Report

    Report Number
    3005075696-2021-00058
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 30, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE SOFTWARE EXPORTS AND LOGS DETERMINED THE COMPLAINT WAS CONFIRMED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. ANALYSIS REVIEWED THE PLANNING MADE IN THE OR. A SKIVING POTENTIAL OF LATERAL SLOPE EXISTS IN RIGHT AND LEFT L3 AND LEFT L4, AND A MEDIAL SKIVING POTENTIAL AT RIGHT L4. IT WAS REPORTED THAT "AN AP IMAGE WAS TAKEN AND THE SCREWS ON THE LEFT SIDE WERE FOUND TO BE LATERAL BY 3.5-10 MM. THE LEFT L3 AND L4 SCREWS WERE REMOVED DURING THE PROCEDURE. A POST OPERATIVE CT SCAN WAS DONE OF THE RIGHT SIDE AND THE SCREWS WERE MEDIAL IN THE CANAL." NO POST OP IMAGES WERE PROVIDED. ANALYSIS REVIEWED THE PLANNING AND THE SURGICAL WORKFLOW AND CONCLUDED THE PROBABLE ROOT CAUSE OF THE DEVIATION EXPERIENCED IN THE OR IS PATIENT SHIFT, COMBINED WITH A POSSIBLE CONTRI BUTION OF A CORTICAL SLOPE IN THE PLANNING. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A SCAN & PLAN CASE FOR L3-L4 OLIF WITH PERC SCREWS WAS COMPLETED. THE PROCEDURE STARTED BY TAKING A SPIN WITH THE O-ARM AND SENDING THE IMAGES TO THE GUIDANCE SYSTEM FOR PLANNING. WHILE PLANNING FOR THE SCREWS WAS DONE, THE SURGEON DID THE EXPOSURE FOR THE OLIF.  THE SURGEON THEN EXECUTED THE SCREWS, PERFORMED THE OLIF, AND THEN WENT BACK TO PLACE RODS.  SCOUT SHOTS TAKEN DURING THE PROCEDURE SHOWED THE SCREWS LOOKED OK IN THE LATERAL VIEW. ANOTHER LATERAL IMAGE WAS DONE AND THE SCREWS LOOKED TO BE IN A DIFFERENT POSITION. AN AP IMAGE WAS TAKEN AND THE SCREWS ON THE LEFT SIDE WERE FOUND TO BE LATERAL BY 3.5-10 MM. THE LEFT L3 AND L4 SCREWS WERE REMOVED DURING THE PROCEDURE. A POST OPERATIVE CT SCAN WAS DONE OF THE RIGHT SIDE AND THE SCREWS WERE MEDIAL IN THE CANAL. A REVISION WAS DONE TO REMOVE THE RIGHT SIDE SCREWS. NO TROUBLESHOOTING WAS DONE DURING THE PROCEDURE SINCE THE SURGEON THOUGHT THE DEVIATION MAY HAVE BEEN CAUSED WHEN TRYING TO TIGHTEN THE RODS. IMAGING WAS NOT DONE PRIOR TO THAT. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727455 MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention