{ "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": "3009185973-2018-00258", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181003", "manufacturer_address_2": "", "pma_pmn_number": "PK172444", "date_of_event": "20180919", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181003", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "771429", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181003", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/17/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20181003", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20190624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7929281", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180926", "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": "122449474", "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 WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "122449475", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A FIELD SERVICE ENGINEER WAS INFORMED THAT A PATIENT FROM THE WEEK BEFORE HAD EXPERIENCED A HEMORRHAGE DURING THE ROSA ASSISTED SEEG CASE. THE HOSPITAL WAS INDEPENDENT FOR THIS CASE SO THERE WERE NO ROSA REPRESENTATIVES IN THE CASE. THE DOCTOR MENTIONED THAT THE TRAJECTORY THAT HE THINKS CAUSED THE HEMORRHAGE WAS ONE THAT WAS PLANNED AT THE LAST MINUTE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON THE DAY OF SURGERY AND AN ADDITIONAL SURGERY WAS PERFORMED TO CLEAR THE HEMORRHAGE. ONLY ONE OF THE SEEG ELECTRODES WAS REMOVED IN THIS PROCESS. THE PATIENT IS DOING WELL AND THE NEUROLOGY TEAM IS CURRENTLY MONITORING THE REMAINING ELECTRODES." }, { "mdr_text_key": "312104883", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AN HAEMORRHAGE WAS NOTICED POST-OPERATIVELY DUE TO INACCURATE ELECTRODES PLACEMENT. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. BASED ON THE INVESTIGATION PERFORMED, THE INACCURACY OF THE ELECTRODES IS CONFIRMED. THIS INACCURACY COULD HAVE BEEN CAUSED BY A BRAIN SHIFT ACCORDING TO THE SURGEON BUT IT COULD NOT BE CONFIRMED BY THE ANALYSIS. THE HEMORRHAGE COULD HAVE BEEN CAUSED BY THE UNUSUAL TWISTED SHAPE OF ONE ELECTRODE WHEN IT WAS IMPLANTED IN THE BRAIN, BUT IT COULD NOT BE CONFIRMED WITH AVAILABLE DATA. THIS TWIST CAN BE DUE TO THE METHOD OF IMPLANTATION, THE SURGEON PLANNING AND/OR THE PATIENT ANATOMY. NONE OF THEM COULD BE CONFIRMED." }, { "mdr_text_key": "312104884", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A FIELD SERVICE ENGINEER WAS INFORMED THAT A PATIENT FROM THE WEEK BEFORE HAD EXPERIENCED A HEMORRHAGE DURING THE ROSA ASSISTED SEEG CASE. THE HOSPITAL WAS INDEPENDENT FOR THIS CASE SO THERE WERE NO ROSA REPRESENTATIVES IN THE CASE. THE DOCTOR MENTIONED THAT THE TRAJECTORY THAT HE THINKS CAUSED THE HEMORRHAGE WAS ONE THAT WAS PLANNED AT THE LAST MINUTE. THE PATIENT WAS BROUGHT BACK TO THE OR ON THEDAY OF SURGERY AND AN ADDITIONAL SURGERY WAS PERFORMED TO CLEAR THE HEMORRHAGE. ONLY ONE OF THE SEEG ELECTRODES WAS REMOVED IN THIS PROCESS. THE PATIENT IS DOING WELL AND THE NEUROLOGY TEAM IS CURRENTLY MONITORING THE REMAINING ELECTRODES." } ], "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": "06/24/2019" } ] }