{ "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": "3009185973-2019-00315", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190912", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190812", "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": "20190912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "803293", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190912", "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 3.0", "catalog_number": "ROSA BRAIN", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/23/2020", "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": "20190912", "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": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9002386", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190816", "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": "319850448", "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 AVAILABLE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE CONTACTLESS REGISTRATION WAS PERFORMED PROPERLY AND THAT THE PRE-OPERATIVE IMAGES WERE ACQUIRED WITHOUT GANTRY TILT. HOWEVER, SOME MISSING DATA DID NOT PERMIT TO CHECK THE FUSION ADJUSTMENT AND THE ACCURACY OF THE ELECTRODES POSITIONING. THE USER STATED THAT THE HEMORRHAGE IS UNLIKELY RELATED TO THE ROSA BRAIN DEVICE. ALTHOUGH SOME MISSING DATA NEEDED FOR THE ANALYSIS COULD NOT BE RETRIEVED (POST-OPERATIVE EXAMS AND ADDITIONAL PATIENT INFORMATION), THE INVESTIGATION RESULTS SUGGEST THAT THE DEVICE BEHAVED AS EXPECTED. THE SURGERY WAS ASSISTED BY A ZIMMER BIOMET REPRESENTATIVE. CORRECTED DATA: - B4 DATE OF THIS REPORT - D4 CATALOG NUMBER - G4 DATE RECEIVED BY MANUFACTURER - H2 IF FOLLOW-UP, WHAT TYPE - H3 DEVICE EVALUATED BY MANUFACTURER - H6 EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "319850449", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON FOUND THAT THE PATIENT EXPERIENCED A HEMORRHAGE AFTER THE SEEG PROCEDURE. THE SURGEON STATED THAT THE IMMEDIATE POST-OP CT LOOKED NORMAL. LATER IN THE DAY THE PATIENT BECAME LETHARGIC AND A SECOND CT SCAN WAS TAKEN. THIS SECOND CT INDICATED THAT THERE WAS AN EDEMA. THE SEEG ELECTRODES WERE IMMEDIATELY REMOVED. THE SURGEON STATED THAT IT IS UNKNOWN WHAT COULD HAVE CAUSED THIS TO OCCUR AND THAT IT WAS NOT NOTICEABLE IMMEDIATELY AFTER SURGERY." }, { "mdr_text_key": "162374557", "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": "162374558", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON FOUND THAT THE PATIENT EXPERIENCED A HEMORRHAGE AFTER THE SEEG PROCEDURE. THE SURGEON STATED THAT THE IMMEDIATE POST-OP CT LOOKED NORMAL. LATER IN THE DAY THE PATIENT BECAME LETHARGIC AND A SECOND CT SCAN WAS TAKEN. THIS SECOND CT INDICATED THAT THERE WAS AN EDEMA. THE SEEG ELECTRODES WERE IMMEDIATELY REMOVED. THE SURGEON STATED THAT IT IS UNKNOWN WHAT COULD HAVE CAUSED THIS TO OCCUR AND THAT IT WAS NOT NOTICEABLE IMMEDIATELY AFTER SURGERY." } ], "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" } ] }