{ "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": "3009185973-2019-00244", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190716", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190618", "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": "20190716", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "587353", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190716", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": [ "Image Orientation Incorrect", "Image Orientation Incorrect" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/05/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20190716", "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": "20190904", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8795376", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190618", "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": "312105249", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE MERGE OF THE EXAMS DURING PRE-OPERATIVE PLANNING WAS NOT SATISFYING. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, THE RESOLUTION OF ONE OF THE EXAM WAS BIGGER THAN THE ONE RECOMMENDED IN THE ACQUISITION PROTOCOL. THIS COULD HAVE CAUSED THE ISSUES WITH THE MERGE OF THE IMAGES. IT CAN BE CONSIDERED AS A USE ERROR. AN ISSUE EVALUATION WAS RAISED TO ESCALATE A TREND ON COMPLAINTS RELATED TO ACQUISITION PROTOCOL NOT FOLLOWED." }, { "mdr_text_key": "312105250", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AN AIRO CT WAS TAKEN OF THE PATIENT IN THE PRONE POSITION. THE CT WAS TRANSFERRED ONTO A USB AND LOADED ONTO THE ROBOT. AN AUTOMATIC MERGE WAS PERFORMED; HOWEVER, THE MERGE WAS UNSUCCESSFUL. IT APPEARED THAT THE CT WAS FULLY ROTATED ON THE AXIS AND OVER 45 DEGREES OFF FROM THE MRI. THE MERGE WAS PERFORMED TWICE MORE WITH CUTTING EXTRA SLICES ON THE TOP AND BOTTOM OF THE SET; HOWEVER, THIS DID NOT WORK. A SEMI-AUTOMATIC MERGE WAS ATTEMPTED WITH 5 POINTS, BUT THIS MADE THE IMAGE WORSE. IT WAS CONFIRMED THAT THE AIRO OPTIONS FOR PRONE AND AXIAL CT HAD BEEN SELECTED. ANOTHER MRI WAS LOADED ONTO THE PATIENT (THIS ONE OF A SAGITTAL VIEW) AND MERGED TO THE ORIGINAL MRI ON THE PLAN.THE CT WAS THEN MERGED TO THIS SECOND MRI AND WAS ABLE TO MERGE SUCCESSFULLY. THE SURGEON WAS UPSET THAT THE SOFTWARE COULD NOT PERFORM THE AUTOMATIC MERGE ITSELF AND THAT THERE WAS NO OPTION TO ALIGN THE TWO IMAGES PARTIALLY AND ALLOW THE SOFTWARE TO DO THE AUTOMATIC MERGE FROM THAT POINT. A DELAY OF OVER AN HOUR OCCURRED DURING THIS TIME WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS WAS AN RNS CASE." }, { "mdr_text_key": "151195878", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "151195879", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN AIRO CT WAS TAKEN OF THE PATIENT IN THE PRONE POSITION. THE CT WAS TRANSFERRED ONTO A USB AND LOADED ONTO THE ROBOT. AN AUTOMATIC MERGE WAS PERFORMED; HOWEVER, THE MERGE WAS UNSUCCESSFUL. IT APPEARED THAT THE CT WAS FULLY ROTATED ON THE AXIS AND OVER 45 DEGREES OFF FROM THE MRI. THE MERGE WAS PERFORMED TWICE MORE WITH CUTTING EXTRA SLICES ON THE TOP AND BOTTOM OF THE SET; HOWEVER, THIS DID NOT WORK. A SEMI-AUTOMATIC MERGE WAS ATTEMPTED WITH 5 POINTS, BUT THIS MADE THE IMAGE WORSE. IT WAS CONFIRMED THAT THE AIRO OPTIONS FOR PRONE AND AXIAL CT HAD BEEN SELECTED. ANOTHER MRI WAS LOADED ONTO THE PATIENT (THIS ONE OF A SAGITTAL VIEW) AND MERGED TO THE ORIGINAL MRI ON THE PLAN. THE CT WAS THEN MERGED TO THIS SECOND MRI AND WAS ABLE TO MERGE SUCCESSFULLY. THE SURGEON WAS UPSET THAT THE SOFTWARE COULD NOT PERFORM THE AUTOMATIC MERGE ITSELF AND THAT THERE WAS NO OPTION TO ALIGN THE TWO IMAGES PARTIALLY AND ALLOW THE SOFTWARE TO DO THE AUTOMATIC MERGE FROM THAT POINT. A DELAY OF OVER AN HOUR OCCURRED DURING THIS TIME WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS WAS AN RNS CASE." } ], "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": "09/04/2019" } ] }