{ "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": "3009185973-2019-00124", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190409", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190312", "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": "20190409", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "291185", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190409", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/04/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20190409", "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": "20200228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8494964", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190312", "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": "317589964", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT INACCURACY FOR SEVERAL ELECTRODES WAS NOTED DURING THE POST-OPERATIVE FUSION AND A CEREBRAL HEMORRHAGE OCCURRED ON TRAJECTORY 7. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. TECHNICAL INVESTIGATION DID NOT PERMIT TO DETERMINE THE ROOT CAUSE OF THE HEMORRHAGE OR INACCURACY. THE ORIGIN OF THE HEMORRHAGE REMAINS UNKNOWN, BUT IT COULD BE DUE TO AN ERROR OF PLANNING. THE ANALYSIS OF AVAILABLE DATA DID NOT REVEAL ANY DEVICE FAILURE. THE DEVICE OPERATED AS SPECIFIED. ALL THE ELECTRODES WERE IMPLANTED ACCURATELY AT THEIR ENTRY POINT. NOTE : THE SURGEON DID NOT PERFORM THE VERIFICATION STEP PROPERLY REGARDING THE IFU RECOMMENDATION BUT IT DOES NOT APPEAR TO BE RELATED TO THE EVENTS. 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": "317589965", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT APPROXIMATELY 2:00 PM, POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED SMALL HEMORRHAGE NEAR THE SURFACE OF TRAJECTORY 7. SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. THEN, FUSION OF POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED 3 ELECTRODES PLACED MORE THAN 10 MM DEEPER THAN PLANNED TRAJECTORIES: TRAJECTORY 1, TRAJECTORY 3, AND TRAJECTORY 4. OTHER ELECTRODES WERE PLACED WITH SUFFICIENT ACCURACY, AND SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. PATIENT WAS IN THE ROOM AND ANESTHETIZED, INCISIONS WERE MADE, NO DELAY TO SURGERY, NO CLINICAL CONSEQUENCES." }, { "mdr_text_key": "141307299", "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": "141307300", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT APPROXIMATELY 2:00 PM, POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED SMALL HEMORRHAGE NEAR THE SURFACE OF TRAJECTORY 7. SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. THEN, FUSION OF POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED 3 ELECTRODES PLACED MORE THAN 10 MM DEEPER THAN PLANNED TRAJECTORIES: TRAJECTORY 1, TRAJECTORY 3, AND TRAJECTORY 4. OTHER ELECTRODES WERE PLACED WITH SUFFICIENT ACCURACY, AND SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. PATIENT WAS IN THE ROOM AND ANESTHETIZED, INCISIONS WERE MADE, NO DELAY TO SURGERY, NO CLINICAL CONSEQUENCES." } ], "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": "02/28/2020" } ] }