{ "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": "3009185973-2020-00117", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200402", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200325", "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": "20200402", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "378379", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200402", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/23/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20200402", "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": "20201027", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9914807", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200325", "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": "315287393", "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 THE LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED CONFIRMED THAT THE DEVICE DID NOT SHOW ANY ANOMALIES THAT COULD HAVE BEEN RELATED TO THE BLEEDING. THE POST-OPERATIVE MRI SHOWS THAT THE TRACE LEFT BY THE BIOPSY NEEDLE IS ACCURATE AND ALIGNED WITH THE PLANNED TRAJECTORY. BLEEDING IS NOT RARE AFTER A BIOPSY, IT IS A COMMON COMPLICATION ENCOUNTERED. CORRECTED DATA: B4 DATE OF THIS REPORT, 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": "315287394", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SITE WAS DOING A BIOPSY CASE WITHOUT THE PRESENCE OF A FIELD SERVICE ENGINEER (FSE). AN FSE WAS SUPPORTING THE CASE THROUGH FACETIME VIA CELLPHONE. AS THE SURGEON WAS PULLING OUT THE BIOPSY NEEDLE FOR THE FINAL CORE TO BE TAKEN, AN INTER-OP. BLEED OCCURRED. THE SURGEON EXPLAINED THE TYPE OF TUMOR THAT THIS PATIENT HAD WAS NORMALLY SURROUND BY A LOT OF VASCULAR STRUCTURES SURROUNDING THE TUMOR. HE SAID THE ROSA WAS ACCURATE AND THERE WERE NO ISSUES WITH ROSA. THE BLEED WAS CAUSED BY THE TUMOR. THE PATIENT WAS CLEARED AND DISCHARGED FROM THE HOSPITAL WITHIN 48 HOURS OF THE SURGERY." }, { "mdr_text_key": "189883042", "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 IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "189883043", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SITE WAS DOING A BIOPSY CASE WITHOUT THE PRESENCE OF A FIELD SERVICE ENGINEER (FSE). AN FSE WAS SUPPORTING THE CASE THROUGH (B)(6) VIA CELLPHONE. AS THE SURGEON WAS PULLING OUT THE BIOPSY NEEDLE FOR THE FINAL CORE TO BE TAKEN, AN INTER-OP BLEED OCCURRED. THE SURGEON EXPLAINED THE TYPE OF TUMOR THAT THIS PATIENT HAD WAS NORMALLY SURROUND BY A LOT OF VASCULAR STRUCTURES SURROUNDING THE TUMOR. HE SAID THE ROSA WAS ACCURATE AND THERE WERE NO ISSUES WITH ROSA. THE BLEED WAS CAUSED BY THE TUMOR. THE PATIENT WAS CLEARED AND DISCHARGED FROM THE HOSPITAL WITHIN 48 HOURS OF THE 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": "10/27/2020" } ] }