BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 13058912 · Received December 22, 2021

    Report

    Report Number
    3009185973-2021-00186
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS AND THE PATIENT FOLDER HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT ALL TRAJECTORIES WERE IMPLANTED ACCURATELY AT THE ENTRY POINT. THE PRESUMED INACCURACY WAS DUE TO AN POOR QUALITY FUSION OF THE POST-OPERATIVE SCAN PERFORMED BY THE USER. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE (CR) RECEIVED TEXT MESSAGES FROM SURGEON USER DR. (B)(6) WHERE DR. (B)(6) NOTED THAT THE LAST TWO SEEG CASES HAVE BEEN 'OFF AT ENTRANCE AND TARGET'. CR NOTED THAT A SUCCESSFUL PREVENTIVE MAINTENANCE PASSED IN THE PAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965728 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