{ "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": "3009185973-2020-00111", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200401", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200305", "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": "20200401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "377607", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200401", "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": "3.1.1.1295", "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": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/02/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20200401", "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": "20201019", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9911003", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200305", "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": "321088702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED AND LED TO THE FOLLOWING OBSERVATIONS : AVAILABLE DATA DID NOT ALLOW TO DETERMINE THE TECHNICAL ROOT CAUSE OF THE INTRACRANIAL HEMORRHAGE. REVIEW OF THE REGISTRATION AND OF THE FUSION DID NOT REVEAL ANY ANOMALY. THE POST-OPERATIVE CT-SCAN WAS NOT SHARED BY THE CUSTOMER, AND WITHOUT THIS CT-SCAN, IT IS IMPOSSIBLE TO DETERMINE WHETHER OR NOT THE ELECTRODE PLACEMENT WAS ACCURATE AND THEREFORE PREVENTS FURTHER INVESTIGATION. THE COMPLAINT DESCRIPTION INDICATES THAT THE PATIENT HAD PREVIOUS BRAIN SURGERIES THAT COULD HAVE CONTRIBUTED TO THE INTRACRANIAL HEMORRHAGE. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS UNKNOWN." }, { "mdr_text_key": "321088703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE EVENT OCCURRED ON (B)(6)2020. WE WERE NOTIFIED OF THE EVENT ON THAT DATE. THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE. THE SURGEON PLACED ALL THE BOLTS, AND ALL DISTANCE NUMBERS WERE OBTAINED. SURGEON THEN STARTED TO PLACE THE ELECTRODES, IT WAS NOTICED THAT THE INTRACRANIAL PRESSURE MONITOR WAS HIGH. SURGEON MADE THE DECISION TO ABORT THE CASE AND GO TO CT. THE BLEED WAS OBSERVED, AND THEY WENT BACK TO THE OR FOR A CRANIOTOMY. THE PATIENT SURVIVED THE SURGERY, AND IS RECOVERING. THE PATIENT HAD PREVIOUS BRAIN SURGERIES THAT IS BELIEVED TO CONTRIBUTE TO THE OUTCOME." }, { "mdr_text_key": "196755361", "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. UDI: (B)(4)." }, { "mdr_text_key": "196755403", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE EVENT OCCURRED ON (B)(6) 2020. WE WERE NOTIFIED OF THE EVENT ON THAT DATE. THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE. THE SURGEON PLACED ALL THE BOLTS, AND ALL DISTANCE NUMBERS WERE OBTAINED. SURGEON THEN STARTED TO PLACE THE ELECTRODES, IT WAS NOTICED THAT THE INTRACRANIAL PRESSURE MONITOR WAS HIGH. SURGEON MADE THE DECISION TO ABORT THE CASE AND GO TO CT. THE BLEED WAS OBSERVED, AND THEY WENT BACK TO THE OR FOR A CRANIOTOMY. THE PATIENT SURVIVED THE SURGERY, AND IS RECOVERING. THE PATIENT HAD PREVIOUS BRAIN SURGERIES THAT IS BELIEVED TO CONTRIBUTE TO THE OUTCOME." } ], "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": "10/19/2020" } ] }