{ "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": "3009185973-2019-00219", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190620", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190523", "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": "20190620", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "511149", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190620", "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": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/27/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20190620", "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": "20200528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8716117", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190523", "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": "148540903", "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": "148540904", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SEEG PROCEDURE WITH ROSA COMPLETED SUCCESSFULLY WITH 16 TRAJECTORIES, BILATERAL. UPON POST-OPERATIVE CT IMAGING, IT WAS NOTED THAT THERE WAS A SIGNIFICANT BLEED. THE SURGEON DETERMINED THAT THE BLEED WAS LIKELY VENOUS, AND DID NOT APPEAR TO CAUSE MASS DISPLACEMENT. DURING ONE OF THE TRAJECTORIES, THE SURGEON DID NOT PASS AN OBTURATOR OR CANNULA PRIOR TO PASSING THE ELECTRODE. THE SURGEON BELIEVED THAT THE ELECTRODE MAY HAVE SKIVED DUE TO THE BLEED. THE SURGEON DECLINED A POST-OPERATIVE IMAGE FUSION TO THE ORIGINAL ROSA PLAN. HE STATED THAT THE ELECTRODES WERE PLACED ACCURATELY BUT THE ISSUE REGARDING THE BLEED WAS RELATED TO THE OBTURATOR." }, { "mdr_text_key": "318035766", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SEEG PROCEDURE WITH ROSA COMPLETED SUCCESSFULLY WITH 16 TRAJECTORIES, BILATERAL. UPON POST-OPERATIVE CT IMAGING, IT WAS NOTED THAT THERE WAS A SIGNIFICANT BLEED. THE SURGEON DETERMINED THAT THE BLEED WAS LIKELY VENOUS, AND DID NOT APPEAR TO CAUSE MASS DISPLACEMENT. DURING ONE OF THE TRAJECTORIES, THE SURGEON DID NOT PASS AN OBTURATOR OR CANNULA PRIOR TO PASSING THE ELECTRODE. THE SURGEON BELIEVED THAT THE ELECTRODE MAY HAVE SKIVED DUE TO THE BLEED. THE SURGEON DECLINED A POST-OPERATIVE IMAGE FUSION TO THE ORIGINAL ROSA PLAN. HE STATED THAT THE ELECTRODES WERE PLACED ACCURATELY BUT THE ISSUE REGARDING THE BLEED WAS RELATED TO THE OBTURATOR." }, { "mdr_text_key": "318035787", "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 DETAILED ANALYSIS OF SOFTWARE LOGS CONCLUDED THAT THE REGISTRATION OF THE PATIENT WAS PROPERLY EXECUTED. ELEMENTS PROVIDED FOR INVESTIGATION DID NOT PERMIT TO PERFORM A COMPLETE ANALYSIS OF THE PATIENT FOLDER. BASED ON THE INVESTIGATION PERFORMED, NO TECHNICAL ROOT CAUSE CAN BE CONFIRMED SINCE EVENT IS NON-VERIFIABLE. THE SURGEON STATED THAT THE BLEEDING WAS DUE TO LACK OF OBTURATOR USE DURING FIRST TRAJECTORIES IMPLANTATION. CORRECTED DATA: B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, AND H6 EVENT PROBLEM AND EVALUATION CODES." } ], "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": "06/24/2020" } ] }