BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN + SPINE

    MDR report key: 12882859 · Received November 29, 2021

    Report

    Report Number
    3009185973-2021-00182
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    October 27, 2021
    Report Date
    April 26, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244033765
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT AN INACCURACY OF 3.5MM TO 4.5MM IS CONFIRMED FOR THE FIRST SIX TRAJECTORIES IMPLANTED. THE CONTACTLESS REGISTRATION WAS PERFORMED CORRECTLY, ALTHOUGH NO ENTRY POINT WAS VERIFIED WITH THE DISTANCE SENSOR BEFORE GOING TO GUIDANCE WHICH IS RECOMMENDED IN THE INSTRUCTIONS FOR USE. THE FUSION BETWEEN THE PRE-OPERATIVE MRI AND CT EXAMS SHOWED A SMALL SHIFT, BUT THIS COULD NOT EXPLAIN THE ELECTRODE PLACEMENT INACCURACY. THE INACCURACY OF THE SIX ELECTRODES COULD BE DUE TO AN UNDETECTED MOVEMENT OF THE HEAD FOLLOWING THE REGISTRATION. THEN, A SECOND REGISTRATION WAS PERFORMED WITH THE POINTER PROBE. THE REGISTRATION ACCURACY WAS NOT CORRECTLY VERIFIED AND MARKERS WERE INCORRECTLY PLACED. RECOMMENDED PLACEMENT OF MARKERS IS WRITTEN IN THE INSTRUCTIONS FOR USE. AFTER THIS REGISTRATION, THE OTHER FIVE TRAJECTORIES WERE IMPLANTED. THESE TRAJECTORIES SEEM TO BE ACCURATE, ALTHOUGH THIS COULD NOT BE CONFIRMED BECAUSE THE POST-OPERATIVE SCAN WAS NOT PROVIDED FOR ANALYSIS. ANALYSIS SHOWS NO MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THE PRELIMINARY ANALYSIS OF SOFTWARE LOGS AND PATIENT FILES REVEALED THAT THE CONTACTLESS REGISTRATION WAS PERFORMED CORRECTLY BEFORE SURGERY, ALTHOUGH NO ENTRY POINT WAS VERIFIED WITH THE DISTANCE SENSOR BEFORE GOING TO GUIDANCE. THE FUSION SHOWS NO ISSUE. AN INACCURACY OF 3.5MM TO 4.5MM IS CONFIRMED FOR THE FIRST SIX TRAJECTORIES IMPLANTED. THEN, A SECOND REGISTRATION WAS PERFORMED WITH THE POINTER PROBE. AFTER THIS REGISTRATION, THE OTHER FIVE TRAJECTORIES WERE IMPLANTED. THESE TRAJECTORIES SEEM TO BE ACCURATE, ALTHOUGH THIS COULD NOT BE CONFIRMED BECAUSE THE POST-OPERATIVE SCAN SHOWING THESE TRAJECTORIES WAS NOT PROVIDED FOR ANALYSIS. AT THIS POINT, OUR ANALYSIS SHOWS NO MALFUNCTION OF THE DEVICE. MEDICAL DEVICE: UDI#: (B)(4).

    Description of Event or Problem · 0

    ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE HOUSTON VA, IN WITH ROBOT S/N (B)(6). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY (B)(6), AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE (B)(6), THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY.

    Description of Event or Problem · 0

    ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE (B)(6), IN WITH ROBOT S/N (B)(4). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY 27TH OF OCTOBER, AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE 28TH, THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784547 ROSA ONE BRAIN + SPINE ROSA ONE HAW MEDTECH SAS ROSA ONE 3.1 3.1.4.1652 03760244033765

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other