{ "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": "2026-09-22", "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": "3009185973-2020-00123", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200409", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200401", "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": "20200409", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "405665", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200409", "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": "PC PLANNING ROSA ONE - USA", "catalog_number": "ROSAS00503", "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", "Computer Software Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/05/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20200409", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200506", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9943094", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318001261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW WERE NOT PERFORMED BASED ON THE LOW SEVERITY OF THIS COMPLAINT. THE PLANNING STATION AND ROBOT CONFIGURATION WERE REVIEWED BY A COMPANY FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER SITE. THIS ANALYSIS CONCLUDED THAT THE IMPOSSIBILITY TO OPEN A PATIENT FOLDER FROM THE ROBOT ON THE PLANNING STATION WAS DUE TO A DIFFERENCE BETWEEN THE ROBOT LICENSE AND THE PLANNING STATION LICENSE. THE ORIGIN OF THIS DIFFERENCE IS THE 'FRAME PLANNING AND REGISTRATION MODULE' WHICH WAS DISABLED ON THE PLANNING STATION DUE TO A MISTAKE OF THE FSE DURING THE SOFTWARE UPGRADE FROM ROSA BRAIN TO ROSA ONE. THE LICENSE OF THE PLANNING STATION HAS BEEN RENEWED WHICH FIXED THE PROBLEM. CORRECTED DATA: B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, H6 EVENT PROBLEM AND EVALUATION CODES, AND H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "318001262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6)2020 , THE SURGEON CONTACTED THE COMPANY FIELD SERVICE ENGINEER (FSE) VIA EMAIL TO RAISE THE COMPLAINT THAT IT IS IMPOSSIBLE TO SUCCESSFUL IMPORT A PLAN FROM THE ROBOT TO THE PLANNING STATION. THE SURGEON ATTEMPTED TO USE DIFFERENT USBS IN EXPORTING THE PLAN FROM THE ROBOT, HOWEVER STILL RECEIVED THE \"IMPOSSIBLE TO LOAD PATIENT FOLDER\" WHEN TRYING TO OPEN THE PLAN IN THE PLANNING STATION. THE SURGEON DID REPORT HOWEVER, THAT THERE WAS NO ISSUE IN EXPORTING A PATIENT FOLDER FROM THE PLANNING STATION AND IMPORTING TO THE ROBOT. A FSE WENT ONSITE ON (B)(6)2020 AND COMPARED THE LICENSES ON THE PLANNING STATION AND THE ROBOT. IT WAS FOUND THAT THE PLANNING STATION'S LICENSE WAS MISSING ACCESS TO \"FRAME REGISTATION\" AND THUS THE LICENSES ON THE ROBOT AND THE PLANNING STATION DID NOT MATCH. THE LICENSE GENERATOR WAS UTILIZED ON THE PLANNING STATION TO CREATE A NEW LICENSE (TO MATCH THE LICENSE ON THE ROBOT). THE PATIENT FOLDER FROM THE ROBOT WAS THEN ABLE TO BE SUCESSFULLY IMPORTED ON THE PLANNING STATION. IT WAS ALSO TESTED THAT PATIENT FOLDERS CREATED ON THE PLANNING STATION COULD BE IMPORTED TO THE ROBOT. THE ISSUE WAS THEREFORE RESOLVED." }, { "mdr_text_key": "192021502", "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": "192021523", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2020, THE SURGEON CONTACTED THE COMPANY FIELD SERVICE ENGINEER (FSE) VIA EMAIL TO RAISE THE COMPLAINT THAT IT IS IMPOSSIBLE TO SUCCESSFUL IMPORT A PLAN FROM THE ROBOT TO THE PLANNING STATION. THE SURGEON ATTEMPTED TO USE DIFFERENT USBS IN EXPORTING THE PLAN FROM THE ROBOT, HOWEVER STILL RECEIVED THE \"IMPOSSIBLE TO LOAD PATIENT FOLDER\" WHEN TRYING TO OPEN THE PLAN IN THE PLANNING STATION. THE SURGEON DID REPORT HOWEVER, THAT THERE WAS NO ISSUE IN EXPORTING A PATIENT FOLDER FROM THE PLANNING STATION AND IMPORTING TO THE ROBOT. A FSE WENT ONSITE ON (B)(6) 2020 AND COMPARED THE LICENSES ON THE PLANNING STATION AND THE ROBOT. IT WAS FOUND THAT THE PLANNING STATION'S LICENSE WAS MISSING ACCESS TO \"FRAME REGISTRATION\" AND THUS THE LICENSES ON THE ROBOT AND THE PLANNING STATION DID NOT MATCH. THE LICENSE GENERATOR WAS UTILIZED ON THE PLANNING STATION TO CREATE A NEW LICENSE (TO MATCH THE LICENSE ON THE ROBOT). THE PATIENT FOLDER FROM THE ROBOT WAS THEN ABLE TO BE SUCCESSFULLY IMPORTED ON THE PLANNING STATION. IT WAS ALSO TESTED THAT PATIENT FOLDERS CREATED ON THE PLANNING STATION COULD BE IMPORTED TO THE ROBOT. THE ISSUE WAS THEREFORE RESOLVED." } ], "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": "05/06/2020" } ] }