BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 22891716 · Received August 25, 2025

    Report

    Report Number
    3009185973-2025-00010
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    March 3, 2025
    Report Date
    August 25, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034793
    PMA / PMN Number
    K214065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ASSOCIATED SOFTWARE LOGS WERE PROVIDED TO THE POST MARKET SURVEILLANCE TEAM AND ANALYZED BY A SUBJECT MATTER EXPERT (SME). BASED ON THE LOGS AND THE ELECTRODE MEASUREMENT ANALYSIS PERFORMED, A TRAJECTORY INACCURACY WAS IDENTIFIED. THE AVERAGE ELECTRODE DEVIATION WAS 7.05 MM OFF OF THE PLANNED ENTRY POINT. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: THE USER PERFORMED MANUAL BONE FIDUCIAL REGISTRATION WITH THE POINTER AND ACHIEVED A PASSING RMS (ROOT MEAN SQUARE) RESULT. THE REGISTRATION VERIFICATION WAS COMPLETED WITH MULTIPLE VALIDATION POINTS THAT EXCEEDED THE DEVICE SPECIFICATION LIMIT. THE LOGS SHOW THE SOFTWARE NOTIFIED THE USER THAT ¿A SIGNIFICANT ERROR HAS BEEN DETECTED ON THIS POINT¿ FOR THE FOUR VERIFICATION POINTS THAT WERE ABOVE THE THRESHOLD. BASED ON THE REGISTRATION VERIFICATION SCREENSHOTS TAKEN BY THE SOFTWARE, STEP 3 WAS PERFORMED ON A BONE FIDUCIAL, WHICH IS NOT RECOMMENDED. NO ISSUES WERE OBSERVED IN THE FUSIONS BETWEEN THE MRI PLANNING EXAM AND THE CT EXAM USED FOR REGISTRATION. NO SHIFT WAS OBSERVED BETWEEN THE PRE OP AND POST OP CT EXAMS. THE TRAJECTORY MEASUREMENT ANALYSIS WAS PERFORMED BY THE SME ON THE POST OP ¿POSTOP OARM¿ CT EXAM. THE ACTUAL TRAJECTORY DEVIATED FROM THE PLANNED TRAJECTORY BY 7.05 MM, WHICH IS ABOVE THE SPECIFICATION LIMIT OF THE SYSTEM. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ACCURACY VERIFICATION PROCEDURE SECTION OF THE DBZ BRAIN APPLICATION USER MANUAL RECOMMENDS THAT IF TOO HIGH OF AN ERROR IS DETECTED ON A POINT DURING THE VERIFICATION PROCESS, THE USER SHOULD VISUALLY CHECK THE POINT AND REDO REGISTRATION, IF NECESSARY. IN THIS CASE, THE USER CHOSE TO VALIDATE THE HIGH ERRORS AND PROCEED WITH THE CASE, WHICH IS NOT ADVISED. ADDITIONALLY, SECTION ACCURACY VERIFICATION PROCEDURE OF THE DBZ BRAIN APPLICATION USER MANUAL PROVIDES ADEQUATE INSTRUCTIONS ON PERFORMING VERIFICATION TO OBTAIN OPTIMAL SYSTEM PERFORMANCE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AFTER THE REPORTED EVENT FOR A REGULAR PREVENTATIVE MAINTENANCE (PM). THE FSE PERFORMED A FULL PREVENTIVE MAINTENANCE, AND ALL TESTS PASSED. THE UNIT WAS CONFIRMED TO BE IN WORKING ORDER. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE ROOT CAUSE FOR THE INTERNAL BRAIN BLEED CANNOT BE DETERMINED. WHILE A TRAJECTORY INACCURACY AND SOME USER ERRORS WERE IDENTIFIED DURING THE REGISTRATION AND VERIFICATION PROCESS, IT CANNOT BE CONFIRMED IF THESE ISSUES CAUSED OR CONTRIBUTED TO THE REPORTED BRAIN BLEED. NO ISSUES WERE FOUND WITH THE ROSA UNIT OR ROSA SOFTWARE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT THAT WAS OPERATED FOR A DEEP BRAIN STIMULATION (DBS) PROCEDURE AND HAD AN INTERNAL BRAIN BLEED FOLLOWING THE PROCEDURE. THE SPECIFIC PROCEDURE PERFORMED WAS REMOVAL OF EXISTING DBS HARDWARE AND PLACING ONE NEW ELECTRODE, UNILATERALLY. IT WAS DISCOVERED AFTER THE POST OP CT SCAN THAT AN INTERNAL BLEED HAD OCCURRED, EITHER DURING THE REMOVAL OF THE EXISTING HARDWARE, OR IMPLANTATION OF NEW HARDWARE. THE NEW DBS ELECTRODE THAT WAS IMPLANTED WAS MANUFACTURED BY MEDTRONIC. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609079 ROSA ONE BRAIN MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS 3.1.6.432 03760244034793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown