{ "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": "3009185973-2019-00175", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190527", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190430", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "436698", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190527", "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": "", "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": [ "Connection Problem", "Connection Problem" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20190527", "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": "20190527", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8644216", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190430", "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": "146208991", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). IT WAS REPORTED THAT ROBOT FAILED TO CONNECT AND THE SURGERY WAS ABORTED. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION A COMMUNICATION FAILURE NOT MENTIONED IN THE COMPLAINT DESCRIPTION OCCURRED WHILE LOADING IMAGES ON THE DEVICE. THIS COMMUNICATION FAILURE WAS DUE TO A KNOWN DESIGN DEFECT. THE TECHNICAL ROOT CAUSE OF THE FAILURE TO CONNECT IS ALSO A KNOWN DESIGN DEFECT. THIS DESIGN DEFECT IS CURRENTLY BEING ESCALATED AS PART OF THE SCOPE OF A CORRECTIVE ACTION." }, { "mdr_text_key": "146208992", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ROBOT WAS TURNED ON AND THE IMAGES WERE LOADED, THE ROBOT WAS CONNECTED TO THE PATIENT AND THE PLAN WAS CREATED BY THE SURGEON. THE O-ARM IMAGES WITH THE FIDUCIALS WERE MERGED. AS THE REGISTRATION WAS ABOUT TO BEGIN THE ROBOT FAILED TO CONNECT DISPLAYING THE MESSAGE \"ROBOT FAILED TO CONNECT\". THE ROBOT WAS OPENED AND CHECKED FOR ANY LOOSE CONNECTIONS WHICH THERE WEREN'T ANY, THE ARM WAS MANUALLY RELEASED IN AN ATTEMPT TO ESTABLISH COMMUNICATION. IT WAS SUSPECTED THAT DUE TO THE MOVE THE PCI CARD WAS DISPLACED THEREFORE THE PLACEMENT WAS CHECK WITH NO ERRORS FOUND. FINALLY, ROBOT COULD NOT CONNECT AND SURGERY WAS ABORTED." } ], "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": "" } ] }