BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 20108116 · Received August 30, 2024

    Report

    Report Number
    3009185973-2024-00011
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    February 26, 2024
    Report Date
    July 22, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K214065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FULL ANALYSIS OF THE DATA LOGS WAS PERFORMED. THE LOGS DID CONFIRM THE REPORTED EVENT FOR ELECTRODE INACCURACIES. NO SOFTWARE ANOMALIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE EVENT. IT WAS IDENTIFIED THAT THE REGISTRATION WAS NOT PERFORMED PROPERLY WHICH MAY CONTRIBUTE TO THE SHIFT SEEN. NO VERIFICATION WAS DONE ON ANY ANATOMICAL POINT. VERIFICATION WAS ONLY RUN ON THE LEKSELL FRAME. THUS, IT CANNOT BE CONFIRMED IF THE REGISTRATION WAS ACCURATE. THE ROSA ONE BRAIN APPLICATION USER MANUAL PROVIDES INFORMATION ON THE METHODS FOR REGISTRATION AND WARNS USER THAT REGISTRATION ERROR CAN CAUSE INACCURACIES AND DETAILS THE PROCEDURE TO PERFORM A REGISTRATION AND VERIFICATION. THE REPORTED ELECTRODE PLACEMENT INACCURACIES WERE CONFIRMED WITH A DEVIATION GREATER THAN THE THRESHOLD. THE DEVIATION ANALYSIS SUGGESTS THE HEAD/HEAD HOLDER SHIFTED POSTERIORLY. THE CT USED FOR THE FUSION ALSO CONTAINED MANY ARTIFACTS THAT COULD LEAD TO A BAD FUSION. THERE WAS SLIGHT FUZZINESS OR DISTORTION FOUND THAT COULD HAVE CONTRIBUTED TO THE INACCURACIES SEEN. IN THE USER MANUAL, IT WARNS THE USER TO NOT ACCEPT POOR FUSION QUALITY. IF ANY DOUBT IN THE IMAGE QUALITY OF THE MERGED EXAM (E.G. ARTIFACT, BLURRED AREAS, SHIFT OR OTHER SUSPICIOUS DISPLAY IN THE ROI), REVIEW THE FUSION AND / OR SELECT ANOTHER 3D EXAM. AS PER THE PROVIDED INFORMATION, THE MERGE OF THE O-ARM PRE-OP SCAN TO THE MRI SCAN WAS ROTATED IN THE SAGITTAL PLANE. THIS WOULD ALIGN TO THE DIRECTIONAL SHIFT OF THE ELECTRODES AND WOULD BE THE MOST LIKELY CONTRIBUTING FACTOR TO THE DISCREPANCIES. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED FOR A SEEG CASE, AFTER GETTING THE POST OPERATIVE SCAN IT WAS NOTED TWO FRONT ELECTRODES, L OF AND TRAJECTORY 1, WERE OFFSET BY A SIGNIFICANT AMOUNT. OTHER ELECTRODES WERE ALSO SHIFTED BUT NOT TO THE SAME DEGREE. IT WAS CONCLUDED THAT THE MERGE OF THE O-ARM PRE-OP SCAN TO THE MRI SCAN WAS ROTATED IN THE SAGITTAL PLANE. THE POST-OP SCAN WAS MERGED TO THE MRI SCAN. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED. 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
    1912457 ROSA ONE BRAIN MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS N/A 3.1.6.276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown