{ "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": "3009185973-2018-00283", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181023", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20181002", "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": "20181023", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "837641", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181023", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/29/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20181023", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20190409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7994670", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181002", "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": "312102568", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT EXPERIENCED A CORTICAL BLEEDING DURING A SEEG SURGERY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. WORKFLOW OF THE SURGERY WAS REVIEWED AND RECREATED AT MANUFACTURING SITE. ACCORDING TO TECHNICAL INVESTIGATION THE DEVICE WORKED AS EXPECTED, THERE WAS NO MALFUNCTION. THE MOST PROBABLE ROOT CAUSES OF THIS EVENT WOULD BE EITHER AN INCORRECT FUSION OR AN INELASTIC MOVEMENT OF THE HEAD IN THE FRONTAL DIRECTION. THE SURGEONS AGREED THAT THE BONE BLEED OCCURRED BECAUSE THE OBTURATOR WAS PASSING THROUGH A VESSEL, AND DID NOT RESULT FROM AN ISSUE WITH THE ROSA BRAIN DEVICE." }, { "mdr_text_key": "312102569", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A FIELD SERVICE ENGINEER WAS NOTIFIED THAT ROSA SEEG SURGERY WAS POSTPONED AFTER 5 ELECTRODES WERE ALREADY IMPLANTED DUE TO A CORTICAL BLEED. THE FIELD SERVICE ENGINEER WAS NOT PRESENT FOR THIS CASE. SURGEON INDICATED THAT THE PATIENT IS DOING WELL ENOUGH TO PROCEED WITH SECOND ROUND OF ELECTRODE IMPLANTATION ON (B)(6) 2018." }, { "mdr_text_key": "124677200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "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": "124677201", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A FIELD SERVICE ENGINEER WAS NOTIFIED THAT ROSA SEEG SURGERY WAS POSTPONED AFTER 5 ELECTRODES WERE ALREADY IMPLANTED DUE TO A CORTICAL BLEED. THE FIELD SERVICE ENGINEER WAS NOT PRESENT FOR THIS CASE. SURGEON INDICATED THAT THE PATIENT IS DOING WELL ENOUGH TO PROCEED WITH SECOND ROUND OF ELECTRODE IMPLANTATION ON (B)(6) 2018." } ], "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": "04/09/2019" } ] }