{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2020-00134", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200527", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "578133", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200603", "brand_name": "ROSA ONE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Image Display Error/Artifact", "Computer Software Problem", "Image Display Error/Artifact" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/18/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20201218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10113673", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200527", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321718145", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT AN INACCURACY BETWEEN THE REFERENCE EXAMS AND THE POINTS REGISTERED BY THE LASER WAS OBSERVED IN THE AREA OF THE PATIENT'S FOREHEAD DURING THE USER'S DIFFERENT ATTEMPTS TO PERFORM THE AUTOMATIC LASER REGISTRATION. THE MAIN HYPOTHESIS IS THAT THE PATIENT'S ANATOMY WOULD HAVE CHANGED BETWEEN THE DATE OF THE EXAMS AND THE DATE OF THE SURGERY, ALTHOUGH THIS HYPOTHESIS COULD NOT BE CONFIRMED. THE USER FINALLY CHANGED HIS METHOD AND USED THE BONE FIDUCIALS TO PERFORM A MANUAL REGISTRATION. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS UNKNOWN." }, { "mdr_text_key": "321718146", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON FOR A BRAIN SURGERY. THE FIRST LASER REGISTRATION ATTEMPT WAS STARTED AROUND 8:20AM EST, AND THERE WAS AN ERROR MESSAGE GIVEN AFTER PERFORMING ALL THE STEPS. ON THE 3D SEGMENTATION, IT WAS NOTICEABLE THAT THE RED POINT FOR THE TOP OF THE FOREHEAD AND THE BLUE MARKS FOR THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD WERE WELL UNDER THE SKIN. ALL THE OTHER RED POINTS LOOKED GOOD, AND THE BLUE MARKS FOR THE AUTOMATIC AND MANUAL SCANS LOOKED GOOD AS WELL EVERYWHERE ELSE, BUT WAS OFF AT THE TOP OF THE FOREHEAD. WHEN LOOKING AT THE VERIFICATION, ALL POINTS WERE WITHIN THE RED CIRCLE EXCEPT AT THE TOP OF THE FOREHEAD, WHERE IT APPEARED TO BE SHOWING THE LASER AT THE BONE OF THE SKULL INSTEAD OF THE SKIN. THE LASER REGISTRATION WAS ATTEMPTED AGAIN USING THE CT SCAN, BUT THE EXACT SAME RESULT SHOWED, WHERE THE BLUE ZIG ZAG LINES OF THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD APPEARED TO BE CUT OFF ON THE 3D SEGMENTATION, AND THE RED POINT AT THE TOP OF THE FOREHEAD WAS ALSO NOT VISIBLE BECAUSE IT WAS UNDER THE SKIN. THE MRI WAS THEN ATTEMPTED TO BE USED AS THE 3D SEGMENTATION FOR LASER REGISTRATION, BUT THE SAME RESULT OCCURRED. THE SURGEON DECIDED TO SWITCH TO BONE FIDUCIALS AND GET A NEW CT SCAN. THE IMAGING WAS MERGED AND THERE WERE NO OTHER ISSUES DURING THE CASE. THE SURGEON STATED THAT THE IMAGING WAS FROM 2019, BUT THERE WOULD NOT BE ANY CHANGES TO THE PATIENT'S ANATOMY TO GIVE THE RESULTS THAT WERE SHOWN. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS HAD BEEN MADE. THE TOTAL DELAY BETWEEN THE FIRST FAILED LASER REGISTRATION AND MERGING THE BONE FIDUCIAL SCAN WAS AROUND AN HOUR AND A HALF." }, { "mdr_text_key": "199076857", "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. (B)(4)." }, { "mdr_text_key": "199076858", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON FOR A BRAIN SURGERY. THE FIRST LASER REGISTRATION ATTEMPT WAS STARTED AROUND 8:20AM EST, AND THERE WAS AN ERROR MESSAGE GIVEN AFTER PERFORMING ALL THE STEPS. ON THE 3D SEGMENTATION, IT WAS NOTICEABLE THAT THE RED POINT FOR THE TOP OF THE FOREHEAD AND THE BLUE MARKS FOR THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD WERE WELL UNDER THE SKIN. ALL THE OTHER RED POINTS LOOKED GOOD, AND THE BLUE MARKS FOR THE AUTOMATIC AND MANUAL SCANS LOOKED GOOD AS WELL EVERYWHERE ELSE, BUT WAS OFF AT THE TOP OF THE FOREHEAD. WHEN LOOKING AT THE VERIFICATION, ALL POINTS WERE WITHIN THE RED CIRCLE EXCEPT AT THE TOP OF THE FOREHEAD, WHERE IT APPEARED TO BE SHOWING THE LASER AT THE BONE OF THE SKULL INSTEAD OF THE SKIN. THE LASER REGISTRATION WAS ATTEMPTED AGAIN USING THE CT SCAN, BUT THE EXACT SAME RESULT SHOWED, WHERE THE BLUE ZIG ZAG LINES OF THE AUTOMATIC SCAN AT THE TOP OF THE FOREHEAD APPEARED TO BE CUT OFF ON THE 3D SEGMENTATION, AND THE RED POINT AT THE TOP OF THE FOREHEAD WAS ALSO NOT VISIBLE BECAUSE IT WAS UNDER THE SKIN. THE MRI WAS THEN ATTEMPTED TO BE USED AS THE 3D SEGMENTATION FOR LASER REGISTRATION, BUT THE SAME RESULT OCCURRED. THE SURGEON DECIDED TO SWITCH TO BONE FIDUCIALS AND GET A NEW CT SCAN. THE IMAGING WAS MERGED AND THERE WERE NO OTHER ISSUES DURING THE CASE. THE SURGEON STATED THAT THE IMAGING WAS FROM 2019, BUT THERE WOULD NOT BE ANY CHANGES TO THE PATIENT'S ANATOMY TO GIVE THE RESULTS THAT WERE SHOWN. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS HAD BEEN MADE. THE TOTAL DELAY BETWEEN THE FIRST FAILED LASER REGISTRATION AND MERGING THE BONE FIDUCIAL SCAN WAS AROUND AN HOUR AND A HALF. PLUS, THE FSE NOTICED THAT WHEN PERFORMING A LASER REGISTRATION, THERE SHOULD BE A SCREENSHOT TAKEN AT THE MATCHING VERIFICATION SCREEN. FSE BELIEVES THIS SCREENSHOT IS NOT TAKEN ANY MORE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/18/2020" } ] }