BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 17486716 · Received August 9, 2023

    Report

    Report Number
    3009185973-2023-00020
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 22, 2025
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K214065
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). DUE TO LIMITED INFORMATION, THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SCREENSHOTS OF THE MEASUREMENTS NOR THE FIRST REGISTRATION WERE PROVIDED TO SHOW THE DISCREPANCY SEEN DURING THIS EVENT. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WITHIN THE LOG FILES WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN SEEG PROCEDURE, CONTACTLESS REGISTRATION WAS PERFORMED AND VALIDATED SUCCESSFULLY. SIX LEADS ON THE PATIENT¿S RIGHT SIDE WERE INSERTED FOLLOWING STANDARD PROCEDURE. WHEN A MEASUREMENT FOR THE DISTANCE TO TARGET OF THE FIRST LEAD ON THE PATIENT¿S LEFT SIDE WAS OBTAINED A DISCREPANCY BETWEEN THE LEFT AND RIGHT DISTANCES WAS OBSERVED. ON THE SOFTWARE, THE DISTANCE BETWEEN THE TOP OF THE INSTRUMENT TO THE PATIENT¿S SKIN WAS MEASURED TO BE 90MM. THE COMPUTER WAS SHUT DOWN AND RESTARTED AND THE SAME ERROR OCCURRED. WHEN REVISITING THE VERIFICATION STEP OF REGISTRATION WITH THE LASER THE REGISTRATION NO LONGER LOOKED APPROPRIATE. REGISTRATION WAS REPEATED, THE RIGHT SIDED ELECTRODES WERE PLACED SUCCESSFULLY AND THE DEPTH OF THE LEFT SIDED ELECTRODES WERE ADJUSTED. THERE WAS A 90 MINUTE DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013076 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A 3.1.6.276 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown