BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN

    MDR report key: 23072991 · Received September 17, 2025

    Report

    Report Number
    3009185973-2025-00011
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    May 11, 2020
    Report Date
    March 24, 2026
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K231103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A2, A6, B4, B5, B7, G3, H2, H6.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; H2; H4 H6; H11 THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION. THE ROSA LOG FILES FOR THE EVENT WERE NOT AVAILABLE FOR ANALYSIS; AS SUCH FURTHER REVIEW OF THE SOFTWARE PERFORMANCE DURING THE EVENT COULD NOT BE PERFORMED. NO INFORMATION WAS PROVIDED TO CONFIRM A ROSA DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED PAIN SINCE THE PROCEDURE. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED EYE AND FACIAL PAIN SINCE THE PROCEDURE. THE PATIENT HAS REPORTED ISSUES WITH THE LEFT EYE AND EXTREME MEMORY ISSUES ALONG WITH MORE INTENSE AND MORE FREQUENT SEIZURES AS WELL AS FREQUENT MIGRAINE HEADACHES FROM ALL THE INCISIONS AND SCAR TISSUE AND EXTREME ANXIETY. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442639 ROSA ONE BRAIN MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS N/A 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1