BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 14571504 · Received June 2, 2022

    Report

    Report Number
    3009185973-2022-00033
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 4, 2022
    Report Date
    August 3, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT AN INACCURACY BETWEEN 4.5MM AND 7.5MM IS CONFIRMED FOR ALL 18 TRAJECTORIES AT THE ENTRY POINT. THE REGISTRATION COULD HAVE BEEN IMPROVED, BUT IS GLOBALLY ACCURATE. THE INACCURACY IS MOST LIKELY DUE TO AN UNDETECTED MOVEMENT OF THE HEAD. A FUSION ISSUE WAS NOTED, AND IS PROBABLY DUE TO THE SAGITTAL ACQUISITION, WHICH IS NOT RECOMMENDED.

    Description of Event or Problem · 0

    THE MRI IN WHICH THE TRAJECTORIES WERE PLANNED ON AND THE CT WITH THE BONE FIDUCIALS WERE MERGED (SURGEON ACCEPTED THE MERGE), REGISTRATION WAS PERFORMED WITH AN ACCURACY OF 0.31 MM. CLINICAL REPRESENTATIVE (CR) WAS MEASURING BONE THICKNESS AND IT WAS NOTED THAT THE CT WAS NOT ALIGNED WITH MRI, WHEN SURGEON ANALYZED THE TWO IMAGES THEY WERE INDEED SIGNIFICANTLY OFF. SURGEON ASSURED THAT THIS WAS NOT THE CASE WHEN THE MERGE WAS DONE. THE CT IMAGE WAS DELETED, SURGEON AND CR TRIED MERGING THE CT TO THE MRI AGAIN AND THE IMAGES WOULD NOT ALIGN. A NEW MRI WAS MERGED TO THE OLD MRI AND THE MERGE WAS SUCCESSFUL. THE CT WAS THEN MERGED TO THE NEW MRI AND AGAIN THE MERGE WAS SUCCESSFUL. CONTACTLESS REGISTRATION WAS PERFORMED AND ACCEPTED. AFTER THE SURGERY ANOTHER CT WAS TAKEN TO CONFIRM ELECTRODE PLACEMENT, THE NEW CT WAS MERGED TO THE OLD CT AND THE MERGE WAS SUCCESSFUL. HOWEVER, WHEN VERIFYING THE TRAJECTORIES WITH THE PLACED ELECTRODES IT WAS NOTED THAT THE ELECTRODES WERE CLOSE TO 6MM OFF. LEFT SIDE APPEARED TO BE MORE INACCURATE THAN RIGHT SIDE. NO SIGNIFICANT PATIENT IMPACT HAS BEEN NOTED.

    Description of Event or Problem · 0

    THE MRI IN WHICH THE TRAJECTORIES WERE PLANNED ON AND THE CT WITH THE BONE FIDUCIALS WERE MERGED (SURGEON ACCEPTED THE MERGE), REGISTRATION WAS PERFORMED WITH AN ACCURACY OF 0.31 MM. CLINICAL REPRESENTATIVE (CR) WAS MEASURING BONE THICKNESS AND IT WAS NOTED THAT THE CT WAS NOT ALIGNED WITH MRI, WHEN SURGEON ANALYZED THE TWO IMAGES THEY WERE INDEED SIGNIFICANTLY OFF. SURGEON ASSURED THAT THIS WAS NOT THE CASE WHEN THE MERGE WAS DONE. THE CT IMAGE WAS DELETED, SURGEON AND CR TRIED MERGING THE CT TO THE MRI AGAIN AND THE IMAGES WOULD NOT ALIGN. A NEW MRI WAS MERGED TO THE OLD MRI AND THE MERGE WAS SUCCESSFUL. THE CT WAS THEN MERGED TO THE NEW MRI AND AGAIN THE MERGE WAS SUCCESSFUL. CONTACTLESS REGISTRATION WAS PERFORMED AND ACCEPTED. AFTER THE SURGERY ANOTHER CT WAS TAKEN TO CONFIRM ELECTRODE PLACEMENT, THE NEW CT WAS MERGED TO THE OLD CT AND THE MERGE WAS SUCCESSFUL. HOWEVER, WHEN VERIFYING THE TRAJECTORIES WITH THE PLACED ELECTRODES IT WAS NOTED THAT THE ELECTRODES WERE CLOSE TO 6MM OFF. LEFT SIDE APPEARED TO BE MORE INACCURATE THAN RIGHT SIDE. NO SIGNIFICANT PATIENT IMPACT HAS BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184862 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