BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN

    MDR report key: 17315144 · Received July 13, 2023

    Report

    Report Number
    3009185973-2023-00017
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 22, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034793
    PMA / PMN Number
    K214065
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3009185973 - 2023 - 00026 LOG FILES WERE PROVIDED AND REVIEWED BY A SUBJECT MATTER EXPERT (SME). NO PERMANENT ELECTRODES WERE LEFT IMPLANTED; THEREFORE, THE REPORTED INACCURACY COULD NOT BE VERIFIED THROUGH THE LOGS ALONE. HOWEVER, THE REGISTRATION AND VERIFICATION PROCESS WERE STILL ANALYZED. THE REGISTRATION ANALYSIS SHOWS THAT REGISTRATION WAS PERFORMED WITH MARKERS POSITIONED ON THE LEKSELL FRAME PINS INSTEAD OF ACTUAL COMPATIBLE BONE FIDUCIALS. THIS REGISTRATION METHOD IS AN OFF-LABEL USE. PER SECTION 2.4.1.2 BONE FIDUCIALS REGISTRATION: "THIS METHOD REQUIRES THE USE OF BONE FIDUCIALS WHICH ARE IMPLANTED INTO THE PATIENT¿S SKULL. REFER TO THE LIST OF COMPATIBLE DEVICES FOR THE AVAILABLE COMPATIBILITY WITH BONE FIDUCIALS MODELS." ADDITIONALLY, REVIEW OF THE REGISTRATION VERIFICATION INDICATES THAT THE POINTS WERE EITHER VALIDATED WITH IMPORTANT ERRORS DETECTED OR SKIPPED ENTIRELY. WHILE THE USER WAS MOST LIKELY UNABLE TO REACH ANATOMICAL POINTS DUE TO THE PRESENCE OF THE FRAME, SECTION 2.4.2 ACCURACY VERIFICATION PROCEDURE OF THE USER BRAIN MANUAL STATES: ¿THE USER MUST POSITION THE POINTER PROBE OR THE OPTICAL DISTANCE SENSOR ON SEVERAL RELEVANT ANATOMIC LANDMARKS OF THE PATIENT¿S HEAD AND VERIFY THE APPROPRIATE MATCHING OF THE NAVIGATED POSITION ON THE PREOPERATIVE IMAGES.¿ ¿IT IS HIGHLY RECOMMENDED TO CARRY OUT THE VERIFICATION IN ORDER TO OBTAIN OPTIMAL PERFORMANCE.¿ SINCE THE RECOMMENDATIONS FOR REGISTRATION AND VERIFICATION WERE NOT FOLLOWED THERE IS NO GUARANTEE THAT THE REGISTRATION IS ACCURATE REGARDING THE PATIENT¿S HEAD. NO ERRORS WERE FOUND IN THE LOGS THAT WOULD INDICATE THAT THE ROSA SOFTWARE CAUSED OR CONTRIBUTED TO THE INACCURACY. THE REPORTED ISSUE WAS CONFIRMED BY A FIELD SERVICE ENGINEER (FSE) WHO WAS PRESENT TO ASSIST THE PROCEDURE. THE LEKSELL FRAME MOVED DURING REGISTRATION AND DURING THE PROCEDURE, WHICH AFFECTED THE ACCURACY OF THE ELECTRODE PLACEMENT. WHILE THE EFFECTS OF THE FIRST SHIFT WERE CORRECTED BY IMPORTING A NEW REFERENCE EXAM AND REATTEMPTING REGISTRATION, THE EFFECTS OF THE SECOND SHIFT WERE NOT DETECTED UNTIL THE ELECTRODES WERE PLACED FOR AWAKE TESTING. THE SYSTEM SUCCESSFULLY PASSED ALL TESTS DURING THE NEXT PREVENTATIVE MAINTENANCE VISIT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. DURING THE INVESTIGATION, THE REPORTED INACCURACY WAS CONFIRMED. A SHIFT IN THE LEKSELL FRAME ADAPTOR WAS IDENTIFIED BY THE FSE AND USER ERROR WITH THE REGISTRATION AND VERIFICATION PROCESS WERE IDENTIFIED IN THE LOG ANALYSIS. HOWEVER, IT CANNOT BE DETERMINED WHICH ISSUE, OR THE EXTENT, THAT CAUSED OR CONTRIBUTED TO THE INACCURACY. THEREFORE, THE DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. CORRECTED: G4, UPDATED: G3; H2.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AWAKE DBS PROCEDURE USING THE ROSA ROBOT WAS FORCED TO BE ABORTED DUE TO INACCURACY OF STEREOTACTIC GUIDANCE. DURING AWAKE TESTING, SURGICAL TEAM WAS NOT ABLE TO FIND DESIRED RESULTS OF STIMULATION AND CAME TO THE CONCLUSION SOME VARIABLE FORCED THE INACCURACY OF THE ROBOTIC ARM. NO PERMANENT ELECTRODES WERE LEFT IMPLANTED IN THE PATIENT AND THE PATIENT WAS NOT HARMED DUE TO THE INACCURACY. THIS CAUSED A TWO (2) HOUR DELAY AND THE PROCEDURE WILL BE RESCHEDULED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171042 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A 3.1.6.276 03760244034793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other