{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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REGISTRATION WAS DONE VIA CONTACTLESS METHOD ON ROSA AND WAS ACCEPTED BY SOFTWARE BUT VERIFICATION SHOWED LESS THAN OPTIMAL RESULTS. SURGEON STATED THAT HE WAS SATISFIED WITH THE REGISTRATION REGARDLESS OF VERIFICATION AND CASE PROCEEDED. AFTER BOLTS WERE PLACED AND MRI DONE, BOTH TRAJECTORIES WERE FOUND TO BE INACCURATE WHEN COMPARED TO PLANNING. BOTH TRAJECTORIES WERE REDONE USING LEKSELL FRAME AND BOX WITHOUT ROSA ON SECOND ATTEMPT. THERE WAS PATIENT IMPACT, AS BOLTS WERE REMOVED AND TWO ADDITIONAL BOLTS PLACED." }, { "mdr_text_key": "327246040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REVIEW OF AVAILABLE DATA DID NOT PERMIT TO CONFIRM THE INACCURATE PLACEMENT OF THE BOLTS AS THE RELATED MRI EXAM WAS NOT PROVIDED FOR INVESTIGATION. HOWEVER, THE ANALYSIS OF AVAILABLE DATA REVEALED MULTIPLE POTENTIAL FACTORS OF INACCURACY: - THE REGISTRATION WAS VALIDATED WITH INACCURATE VERIFICATION RESULTS. - SIGNIFICANT DIFFERENCES BETWEEN THE ACTUAL MORPHOLOGY OF THE PATIENT DURING THE SURGERY AND THE ONE EXHIBITED IN HIS CT EXAM CANNOT BE EXCLUDED, WHICH COULD EXPLAIN THE INCORRECT RESULTS OF THE CONTACTLESS REGISTRATION, ATTEMPTED THREE TIMES BEFORE VALIDATION. - THE FUSION OF SOME OF THE EXAMS USED DURING THE CASE IS NOT OPTIMAL. THOSE ELEMENTS SUGGEST THAT THE PROCEDURE COULD HAVE LED TO INACCURATE PLACEMENT OF BOLTS, HOWEVER THIS CANNOT BE CONFIRMED AS THE EXAM SHOWING THE BOLTS WAS NOT PROVIDED FOR INVESTIGATION. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G3 DATE RECEIVED BY MANUFACTURER . - H2 IF FOLLOW-UP, WHAT TYPE. - H3 DEVICE EVALUATED BY MANUFACTURER. - H6 ADVERSE EVENT PROBLEM. - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "256559906", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "256559907", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A LASER ABLATION CASE WAS PERFORMED. REGISTRATION WAS DONE VIA CONTACTLESS METHOD ON ROSA AND WAS ACCEPTED BY SOFTWARE BUT VERIFICATION SHOWED LESS THAN OPTIMAL RESULTS. SURGEON STATED THAT HE WAS SATISFIED WITH THE REGISTRATION REGARDLESS OF VERIFICATION AND CASE PROCEEDED. AFTER BOLTS WERE PLACED AND MRI DONE, BOTH TRAJECTORIES WERE FOUND TO BE INACCURATE WHEN COMPARED TO PLANNING. BOTH TRAJECTORIES WERE REDONE USING LEKSELL FRAME AND BOX WITHOUT ROSA ON SECOND ATTEMPT. THERE WAS PATIENT IMPACT, AS BOLTS WERE REMOVED AND TWO ADDITIONAL BOLTS PLACED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "ZAC EUREKA", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/26/2021" } ] }