BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 14073767 · Received April 11, 2022

    Report

    Report Number
    3009185973-2022-00024
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE IDENTIFIER (UDI) #: (B)(4). A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT ALL TEN TRAJECTORIES WERE IMPLANTED INACCURATELY REGARDING THE SPECIFICATIONS, WHICH COULD BE A CAUSE FOR THE HEMORRHAGE. A GLOBAL TREND OF CAUDAL DEVIATION WAS FOUND AND THE MOST ANTERIOR ELECTRODES WERE ALSO DEVIATED SLIGHTLY FORWARD WHICH COULD INDICATE A ROTATION OF THE HEAD IN RELATION TO THE REGISTRATION PERFORMED. THE DEVIATION ANALYSIS ALSO INDICATES THAT MULTIPLE ELECTRODES WERE IMPLANTED TWISTED OR BIAS. THE CURVATURE OF THE ELECTRODE INSIDE THE BRAIN DEPENDS ON VARIOUS FACTORS, INCLUDING,BUT NOT LIMITED TO, THE MATERIAL OF THE ELECTRODE, ITS STIFFNESS, THE PATIENT ANATOMY AND/OR THE METHOD OF IMPLANTATION. IN THIS CASE, FOR MOST OF THEM, THE ELECTRODES SHIFT AT THE ENTRY POINTS ALSO CONTRIBUTED TO THE TARGET POINT ERROR. HOWEVER, NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED. NO DEVICE FAILURE WAS DETECTED. THE DEVICE PASSED THE MAINTENANCES PERFORMED BEFORE AND AFTER THE EVENT. ALTHOUGH THAT THE REGISTRATION COULD HAVE BEEN OPTIMIZED, THE DATA OF ANALYSIS SHOWS THAT IT WAS PROPERLY EXECUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED A TEMPORAL HEMORRHAGE WITH READING AND NAMING DIFFICULTIES. DURING THE SURGERY, THE FUSION WAS GOOD, AS WELL AS THE PATIENT'S POSITION. THE HEAD HOLDER WAS STABLE. THE REGISTRATION COULD HAVE BEEN BETTER DONE (LASER POINTS INSTEAD OF LINES) BUT THE REGISTRATION VALUES WERE ALL GOOD (GREEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900477 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H