BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 16532776 · Received March 13, 2023

    Report

    Report Number
    3009185973-2023-00005
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    January 6, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SOFTWARE THAT WAS USED WITH THIS DEVICE IS A COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED. 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). CONCOMITANT MEDICAL PRODUCTS: PART # ROSAS00500 LEKSELL REGISTRATION PLATES SERIAL# (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.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE SOFTWARE THAT WAS USED WITH THIS DEVICE IS A COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE HAS BEEN A SIGNIFICANT ERROR OF SEEG LEAD PLACEMENT USING ROSA BRAIN DURING SEEG IMPLANTATION CASES. FREESURFER WAS USED TO ANALYZE POST-OP LEAD PLACEMENT AND THERE IS CONSISTENT SYSTEMATIC ERROR OF LEAD PLACEMENT. CALIBRATION PLATES WERE USED FOR FRAME REGISTRATION USING THE ROSA BRAIN ROBOT. SURGEON NOTED THAT THE ERRORS ARE BIG BUT NOT SYSTEMATIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649952 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A N/A 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown