BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 19839649 · Received July 26, 2024

    Report

    Report Number
    3009185973-2024-00008
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    October 30, 2023
    Report Date
    July 22, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034793
    PMA / PMN Number
    K214065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. A FULL ANALYSIS OF THE DATA LOGS WAS PERFORMED. THE LOGS DID CONFIRM THE REPORTED EVENT; ONE OF THE TWENTY ELECTRODES HAD GREATER THAN THE PERFORMANCE SPECIFICATION. NO SOFTWARE ANOMALIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE REGISTRATION WAS NOT PERFORMED PROPERLY WHICH MAY HAVE CONTRIBUTED TO THE SHIFT SEEN. HOWEVER THIS CANNOT BE DEFINITIVELY VERIFIED. NO VERIFICATION WAS DONE ON ANY ANATOMICAL POINT. VERIFICATION WAS ONLY RUN ON SCREWS OF THE LEKSELL FRAME. THE REPORTED ELECTRODE PLACEMENT INACCURACY WAS CONFIRMED WITH A DEVIATION GREATER THAN THE PERFORMANCE SPECIFICATION. THERE WAS AN AVERAGE DEVIATION IN SPECIFICATION FOR THE RIGHT SIDE OF THE PATIENT¿S HEAD. THE DEVIATION ANALYSIS SUGGESTS THERE WAS HEAD MOVEMENT WITH A CENTER OF ROTATION CLOSE TO THE TEMPORAL RIGHT SIDE. THE ROSA ONE BRAIN APPLICATION USER MANUAL PROVIDES INFORMATION ON THE METHODS FOR REGISTRATION AND WARNS USER THAT REGISTRATION ERROR CAN CAUSE INACCURACIES IN REGISTRATION METHODS. REGISTRATION DETAILS THE PROCEDURE TO PERFORM A REGISTRATION AND VERIFICATION. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION AVAILABLE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A POSSIBLE SLIGHT ERROR IN ACCURACY DUE TO THE RESULT OF A MERGE ERROR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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
    1733992 ROSA ONE BRAIN MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS N/A 3.1.6.276 03760244034793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown