BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 14733829 · Received June 17, 2022

    Report

    Report Number
    3009185973-2022-00034
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 6, 2022
    Report Date
    February 7, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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. UDI# : (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A FULL ANALYSIS OF THE PROVIDED LOG FILES WAS PERFORMED. WHILE THE AUTOMATIC FUSION RESULT WAS INSUFFICIENT AND REQUIRED MANUAL ADJUSTMENT, THE DEVICE IS CONSIDERED TO HAVE PERFORMED AS PER SPECIFICATION. HOWEVER THE FAILURE OF THE MANUAL ADJUSTMENT FEATURE TO PROVIDE AN ACCEPTABLE RESULT IS A KNOWN SOFTWARE ANOMALY. A PERFORMANCE IMPROVEMENT OPPORTUNITY FOR THE AUTOMATIC FUSION ALGORITHM IS ALREADY BEING WORKED ON. REGARDING THE INACCURACY ISSUE, THE ANALYSIS CONCLUDED THAT THE PRIOR SURGERY, LED TO AN ACCURATE PLACEMENT OF ELECTRODES WITH ROSA. THE REVIEW PERFORMED 2 WEEKS LATER SEEMED TO HAVE BEEN PERFORMED ON A DISTORTED CT. THE REVISION SURGERY SHOWED THAT THE REPLACED ELECTRODE WAS SHIFTED OVER 2MM AT THE ENTRY POINT BUT WAS ACCURATE AT THE TARGET POINT. HOWEVER, THIS REPLACEMENT WAS PERFORMED ON PURPOSE. THE DEVICE OPERATED AS INTENDED IN REGARDS TO THE REPORTED INACCURACY ISSUE. THEREFORE WITH NO INACCURACY IDENTIFIED, THE MENTIONED FUSION ISSUES ARE NOT CONSIDERED TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INACCURACY. THE FUNCTIONALITY AND ACCURACY OF THE SUBJECT ROSA BRAIN DEVICE WAS VERIFIED DURING A PREVENTIVE MAINTENANCE. NO ISSUES RELATED TO THE REPORTED EVENT WERE OBSERVED, ALL TESTS AND CHECKS PASSED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE REPORTED EVENT AND THE RELATIONSHIP OF THE PRODUCT, IF ANY, TO THE REPORTED INCIDENT OR ADVERSE EVENT AND JUSTIFICATION USED TO MAKE THE DECISION. BASED ON THE INVESTIGATION PERFORMED, NO FAILURE OF THE DEVICE WAS FOUND FOR THE INACCURACY ISSUE. FUSION ISSUES ARE RELATED TO PERFORMANCE IMPROVEMENT AND SOFTWARE ANOMALY BUT ARE NOT CONSIDERED TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INACCURACY. A CORRECTIVE ACTION HAS BEEN PREVIOUSLY INITIATED FOR THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    DURING THE DBS PROCEDURE MULTIPLE O-ARM SPINS WERE MERGED TO THE FIRST BONE FIDUCIAL O-ARM SPIN. ONLY THE LAST O-ARM SPIN PRESENTED A MERGE ISSUE. THE LATEST CT SCAN WAS ROTATED 90 DEGREES OVERLAYING THE FIDUCIAL O-ARM SPIN. ADJUSTMENTS WERE MADE USING THE ROTATION AND TRANSLATION TOOLS, HOWEVER AFTER RECALCULATING, THE SYSTEM IMMEDIATELY REVERTED TO THE ORIGINAL 90 DEGREE MIS-ORIENTATION. SINCE THE SCANS WERE NOT MERGING CORRECTLY AFTER RECALCULATING, IT WAS ATTEMPTED MERGING THE LAST O-ARM CST TO THE ORIGINAL PLANNING MRI. THIS MERGE PRESENTED NO ISSUES AND AFTER CAREFUL OBSERVATION THE SURGEON ACCEPTED THE MERGE ON THE SOFTWARE. THESE LAST O-ARM SPINS DURING THE OPERATION CONFIRMED ACCURATE ELECTRODE PLACEMENT. HOWEVER, 2 WEEKS POST-OPERATION SURGEON CONTACTED ZIMMER BIOMET CLAIMING THE CT SCANS OBTAINED AFTER PROCEDURE AND O-ARMS DURING PROCEDURES DO NOT MATCH RESULTING IN INACCURATE ELECTRODE PLACEMENT. CUSTOMER IS REQUESTING AN INVESTIGATION TO DETERMINE IF THE MERGING SOFTWARE CONTRIBUTED TO INACCURATE ELECTRODE PLACEMENT. PATIENT IMPACT IS UNKNOWN HOWEVER SURGEON INDICATED A REVISION SURGERY MAY BE NECESSARY.

    Description of Event or Problem · 0

    DURING THE DBS PROCEDURE MULTIPLE O-ARM SPINS WERE MERGED TO THE FIRST BONE FIDUCIAL O-ARM SPIN. ONLY THE LAST O-ARM SPIN PRESENTED A MERGE ISSUE. THE LATEST CT SCAN WAS ROTATED 90 DEGREES OVERLAYING THE FIDUCIAL O-ARM SPIN. ADJUSTMENTS WERE MADE USING THE ROTATION AND TRANSLATION TOOLS,HOWEVER AFTER RECALCULATING, THE SYSTEM IMMEDIATELY REVERTED TO THE ORIGINAL 90 DEGREE MIS-ORIENTATION. SINCE THE SCANS WERE NOT MERGING CORRECTLY AFTER RECALCULATING, IT WAS ATTEMPTED MERGING THE LAST O-ARM CST TO THE ORIGINAL PLANNING MRI. THIS MERGE PRESENTED NO ISSUES AND AFTER CAREFUL OBSERVATION THE SURGEON ACCEPTED THE MERGE ON THE SOFTWARE. THESE LAST O-ARM SPINS DURING THE OPERATION CONFIRMED ACCURATE ELECTRODE PLACEMENT. HOWEVER, 2 WEEKS POST-OPERATION SURGEON CONTACTED ZIMMER BIOMET CLAIMING THE CT SCANS OBTAINED AFTER PROCEDURE AND O-ARMS DURING PROCEDURES DO NOT MATCH RESULTING IN INACCURATE ELECTRODE PLACEMENT. CUSTOMER IS REQUESTING AN INVESTIGATION TO DETERMINE IF THE MERGING SOFTWARE CONTRIBUTED TO INACCURATE ELECTRODE PLACEMENT. THE PATIENT WAS REVISED APPROXIMATELY 1.5 MONTHS LATER. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193911 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H