BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN

    MDR report key: 16584229 · Received March 21, 2023

    Report

    Report Number
    3009185973-2023-00009
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 22, 2023
    Report Date
    May 19, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. PREVENTIVE MAINTENANCE PASSED PRIOR TO CASE. NO MAINTENANCE HAS BEEN PERFORMED FOLLOWING THE EVENT. HOWEVER, MORE THAN 10 OTHER SURGERIES USING BONE FIDUCIAL REGISTRATION WERE PERFORMED AFTER THE CASE AND PASSED WITH NO OTHER SIMILAR EVENT REPORTED. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONFIRMED THE REPORTED EVENT. SEVERAL FACTS/ISSUES WERE IDENTIFIED, ALL LIKELY CONTRIBUTING TO THE REPORTED INACCURACY: PATIENT HEAD MOTIONS: AT LEAST ONE HEAD MOTION WAS PROVEN: THE COORDINATES ON WHICH THE ROBOT WAS SENT AT THE BEGINNING OF THE OPERATION AND AT THE END ARE THE SAME RELATIVE TO THE ROBOT BUT ARE DIFFERENT RELATIVE TO THE PATIENT. THE DEFINITIVE CAUSE FOR THE MOVEMENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. INCORRECT FIDUCIAL POSITIONING: MARKERS ARE ALL ON THE LEFT SIDE (SO NOT DISTRIBUTED OVER THE PATIENT HEAD). ADDITIONALLY, ALL OF THEM ARE CLOSE TO IN ONE SAGITTAL PLANE. MOREOVER, SEVERAL TRAJECTORIES ARE ON THE FAR-LEFT SIDE AND NO FIDUCIALS ARE CLOSE TO THIS AREA OF INTEREST. NOT ENOUGH BONE FIDUCIALS: THERE WERE ONLY 4 FIDUCIALS USED DURING THIS SURGERY. INCORRECT VERIFICATION: THE USER SKIPPED THE VERIFICATION STEPS REQUIRED BY ROSANNA. THE SERIAL NUMBER OF THIS DEVICE WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE PATIENT HEAD SHIFT(S) CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THE BONE FIDUCIAL AND VERIFICATION ISSUES IS RELATED TO USER ERROR. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER A SEEG CASE, IT WAS NOTICED ALL OF THE ELECTRODE PLACEMENTS WERE OFF A FAIR AMOUNT. ADDITIONALLY, THERE WERE SOME REGISTRATION ERRORS DURING THE CASE DUE TO THE FACT THAT ONE OF THE FIDUCIALS WAS RIGHT ON TOP OF A TRAJECTORY, THIS LEAD TO THEM DECIDING TO UTILIZE ONLY 4 OUT OF 5 BONE FIDUCIALS FOR REGISTRATION. THE FIRST BONE FIDUCIAL REGISTRATION THEY DID GOT AN RMS OF 1.00 AS THEY DID 4 OUT OF 5 OF THE FIDUCIALS AND THEN VALIDATED. THE SECOND TIME THEY DID REGISTRATION THEY DELETED THE FIFTH BONE FIDUCIAL COMPLETELY SO REGISTRATION UTILIZED ONLY 4 OUT 4 OF THE BONE FIDUCIALS. IT WAS NOTICED THAT THESE TRAJECTORIES WERE STILL OFF BY A GOOD AMOUNT POST-SURGERY. IT WAS NOTICED THAT ONE OF THE FIDUCIALS HAD SHIFTED AFTER LOOKING AT THE SCAN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18277 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A 3.1.6.90 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown