{ "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": "3009185973-2020-00090", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200311", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200228", "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": "20200311", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "280076", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200311", "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", "Computer Software Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/27/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20200311", "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": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9817460", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200228", "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": "319578610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA HAS BEEN PERFORMED AND CONCLUDED THAT THE IMPOSSIBILITY TO LOAD THE PATIENT FOLDER IS DUE TO THE CORRUPTION OF THE CONTENT OF THE HEADER FILE BELONGING TO THE DICOM \"CTCONTRAST\". THE ORIGIN REMAINS UNCERTAIN BUT THE MOST PROBABLE HYPOTHESES ARE THAT THE HEADER FILE WAS INCORRECTLY GENERATED DURING THE CREATION OF THE DICOM OR THAT THE TRANSFER FROM/TO A USB KEY HAS ALTERED ITS CONTENT. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A CORRUPTED DATA." }, { "mdr_text_key": "319578611", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT FOLDER WAS LOADED IN FROM A USB, AND THE COMPANY FIELD SERVICE ENGINEER (FSE) RECEIVED THE ERROR 'IMPOSSIBLE TO LOAD PATIENT FOLDER'. IT WAS CONCLUDED THAT THE CONTRAST/3D THRESHOLD ON THE FIRST IMAGE SET WAS THE PROBLEM. THE VALUES IN THE [3D_THRESHOLD] SECTION WERE DELETED AND REPLACED. ROSANNA WAS LAUNCHED AND THE PATIENT FOLDER DID NOT SHOW UP UNDER THE USB OR UNDER THE SAVED EXAMS. IT WAS ALSO ATTEMPTED TO LOAD THE FOLDER ONTO THE PLANNING LAPTOP AND WITH A DIFFERENT USB, WITH THE SAME RESULT. ULTIMATELY A NEW PATIENT FOLDER WAS CREATED, WITHOUT THE CORRUPTED CT." }, { "mdr_text_key": "196421839", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(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": "196421840", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT FOLDER WAS LOADED IN FROM A USB, AND THE COMPANY FIELD SERVICE ENGINEER (FSE) RECEIVED THE ERROR 'IMPOSSIBLE TO LOAD PATIENT FOLDER'. IT WAS CONCLUDED THAT THE CONTRAST/3D THRESHOLD ON THE FIRST IMAGE SET WAS THE PROBLEM. THE VALUES IN THE [3D_THRESHOLD] SECTION WERE DELETED AND REPLACED. ROSANNA WAS LAUNCHED AND THE PATIENT FOLDER DID NOT SHOW UP UNDER THE USB OR UNDER THE SAVED EXAMS. IT WAS ALSO ATTEMPTED TO LOAD THE FOLDER ONTO THE PLANNING LAPTOP AND WITH A DIFFERENT USB, WITH THE SAME RESULT. ULTIMATELY A NEW PATIENT FOLDER WAS CREATED, WITHOUT THE CORRUPTED CT." } ], "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": "07/28/2020" } ] }