BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 15971881 · Received December 13, 2022

    Report

    Report Number
    3005075696-2022-00089
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    June 29, 2022
    Report Date
    December 19, 2022
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: A1, UPDATED. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9736060K, LOT#: 190801 PRODUCT ID: 9736061K, LOT#: 190718, PRODUCT ID: 9734907, LOT#: 111201, PRODUCT ID: 9734914, LOT#: 200407. 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.

    Additional Manufacturer Narrative · 0

    THE SURGICAL ARM WAS REPLACED AND RETURNED FOR ANALYSIS. ANALYSIS DETERMINED THAT MULTIPLE HARDWARE AND ELECTRICAL FAILURES WERE FOUND WITH THE SURGICAL ARM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ASM0206-01S, SERIAL/LOT #: (B)(4), PRODUCT ID: 9736060K, SERIAL/LOT #: UNK, PRODUCT ID: 9736061K, SERIAL/LOT #: UNK, PRODUCT ID: 9734907, SERIAL/LOT #: UNK, PRODUCT ID: 9734914, SERIAL/LOT #: UNK. FDA CODES: B01, C13 PERTAIN TO PRODUCT ID: ASM0206-01S FDA CODES: B17, C20 PERTAIN TO PRODUCT ID: 9736060K, 9736061K, 9734907, 9734914. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE NAVLOCKS SHOWED TO BE SLIGHTLY INACCURATE, APPROXIMATELY 1 MM. THE MANUFACTURER REPRESENTATIVE RE-REGISTERED THE GUIDANCE SYSTEM AND REORIENTED THE CAMERA TO RESOLVE THE ISSUE. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. NO NEW INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT FOUR NAVLOCKS WERE SHOWING INACCURATE.THE CAUSE OR SUSPECTED CAUSE OF THE NAVLOCKS SHOWING INACCURATE WAS NOT DETERMINED. ONCE THE GUIDANCE SYSTEM WAS REREGISTERED AND THE CAMERA WAS REORIENTED THE NAVLOCKS WERE STILL SHOWING TO BE SLIGHTLY OFF. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY. NAVIGATION WAS SLIGHTLY OFF ON THE SCREEN ONLY, BUT THE SURGEON WAS USING FLURO TO CHECK THE ACCURACY. THE CASE WAS COMPLETED WITH THE SAME NAVLOCKS UNDER FLUORO CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135934 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male