{ "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": "3009185973-2021-00088", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210330", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210301", "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": "20210330", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "484558", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210330", "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": "3.1.4.1650", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/01/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20210330", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210401", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11587362", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210301", "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": "323730206", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO CONCLUDE THAT THE UNEXPECTED SHUTDOWNS OF THE DEVICE DURING THE PROCESS ARE DUE TO A KNOWN VIRTUAL MEMORY MISMANAGEMENT ANOMALY. THE DISAPPEARANCE OF THE PATIENT FOLDER IS A KNOWN ANOMALY, THE CT PRE-OPERATIVE EXAM LOADED DURING THE EVENT CAUSED THE PATIENT FOLDER DISAPPEARANCE FROM THE MENU LIST DUE TO THE MISSING FIELD (0008,0021) SERIES DATE. THESE SOFTWARE ANOMALIES WILL BE ADDRESSED THROUGH OUR DESIGN ISSUES MANAGEMENT PROCESS." }, { "mdr_text_key": "323730207", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT ROSA SOFTWARE SHUTDOWN AFTER PERFORMING FIDUCIAL REGISTRATION, RMS 0.17. AFTER SHUTDOWN, SOFTWARE DISPLAYED INITIAL BOOT UP SCREEN. PATIENT FOLDER WAS NO LONGER VISIBLE. PATIENT FOLDER HAD TO BE RELOADED AND REGISTRATION REPERFORMED. SECOND REGISTRATION WAS DONE VIA CONTACTLESS METHOD. CASE PROCEEDED BUT HAD A SECOND SHUTDOWN DURING GUIDANCE. PATIENT FOLDER WAS STILL VISIBLE AFTER SECOND SHUTDOWN AND RECOVERING TIME WAS LESS THAN ONE MINUTE. REGISTRATION WAS STILL SAVED AND VERIFIED. CASE FINISHED WITHOUT ANY OTHER ERRORS. THERE WAS NO PATIENT IMPACT. DELAY TO CASE WAS AROUND 30 MINUTES." }, { "mdr_text_key": "247286552", "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": "247286553", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ROSA SOFTWARE SHUTDOWN AFTER PERFORMING FIDUCIAL REGISTRATION, RMS 0.17. AFTER SHUTDOWN, SOFTWARE DISPLAYED INITIAL BOOT UP SCREEN. PATIENT FOLDER WAS NO LONGER VISIBLE. PATIENT FOLDER HAD TO BE RELOADED AND REGISTRATION REPERFORMED. SECOND REGISTRATION WAS DONE VIA CONTACTLESS METHOD. CASE PROCEEDED BUT HAD A SECOND SHUTDOWN DURING GUIDANCE. PATIENT FOLDER WAS STILL VISIBLE AFTER SECOND SHUTDOWN AND RECOVERING TIME WAS LESS THAN ONE MINUTE. REGISTRATION WAS STILL SAVED AND VERIFIED. CASE FINISHED WITHOUT ANY OTHER ERRORS. THERE WAS NO PATIENT IMPACT. DELAY TO CASE WAS AROUND 30 MINUTES." } ], "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": "04/02/2021" } ] }