BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 10566750 · Received September 22, 2020

    Report

    Report Number
    1723170-2020-02493
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 16, 2020
    Report Date
    January 12, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: A SOFTWARE INVESTIGATION WAS INITIATED FOR THIS EVENT AND THE CASE WAS REVIEWED. THE REFERENCE FRAME WAS MOVED SLIGHTLY FOR REMOVING THE DRAPES. AND AFTER THE REFERENCE FRAME WAS ADJUSTED TO BE PARALLEL WITH THE DRAPE, IT WAS ACCURATE. THE SOFTWARE IS FUNCTIONING AS DESIGNED. 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

    NO SYSTEM CHECKOUT HAS BEEN PERFORMED AS THERE IS NO PART ORDER. NO PARTS HAVE BEEN RETURNED FOR PRODUCT ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A L2-L5 FUSION. IT WAS REPORTED THAT THERE WERE A FEW INACCURACIES DURING THE CASE. THE PATIENT HAD THREE DRAPES ON WHILE THE IMAGING SYSTEM SPINS WERE TAKEN(ONE WAS BELOW THE REFERENCE FRAME AND TWO WERE CLEAR PLASTIC DRAPES ABOVE THE REFERENCE FRAME). THE FIRST SPIN, ONCE THE DRAPES WERE REMOVED, WAS APPROXIMATELY 10MM INACCURATE. THE SITE TOOK ANOTHER SPIN, REMOVED THE DRAPES, AND IT WAS APPROXIMATELY 4MM INACCURATE. ON THE FINAL SPIN, THE REFERENCE FRAME WAS ADJUSTED TO BE PARALLEL WITH THE DRAPE, AND THERE WAS NO INACCURACY ONCE THE DRAPES WERE REMOVED. THE REFERENCE FRAME WAS ATTACHED TO S1 USING A SPINOUS PROCESS CLAMP. THE PROBABLE CAUSE WAS THOUGHT TO BE THE DRAPE REMOVAL MOVING THE REFERENCE FRAME. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED OVER AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030837 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR