{ "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": "*", "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": "3009185973-2017-00762", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20171108", "manufacturer_address_2": "", "pma_pmn_number": "PK151359", "date_of_event": "20171009", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH 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": "20171108", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "790757", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171108", "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": "N/A", "lot_number": "3.0.0.20", "other_id_number": "N/A", "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": "04/30/2018;04/27/2018", "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": "20171108", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20180504", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7008648", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20171013", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "250774158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST-OPERATIVE EXAM SHOWED MULTIPLE INACCURATE ELECTRODE PLACEMENTS. THE PATIENT APPEARS TO HAVE ROTATED AFTER THE REGISTRATION WAS COMPLETED. THE REGISTRATION APPEARS TO HAVE BEEN WITHIN TOLERANCE, BUT WARNINGS WERE GIVEN REGARDING THE QUALITY OF THE REGISTRATION AND THE USER DECIDED TO PROCEED. THE QUALITY OF THE REGISTRATION APPEARS TO HAVE CONTRIBUTED BUT IS UNLIKELY THE SOLE SOURCE OF THE INACCURACY. THE CAUSE OF THE INACCURACY APPEARS TO BE A HEAD ROTATION AFTER THE COMPLETION OF THE REGISTRATION AS INDICATED BY THE CONSISTENCY OF THE SHIFT OF EACH TRAJECTORY. PREVENTIVE MAINTENANCE PERFORMED FEW DAYS AFTER THE EVENT DID NOT INDICATE ANY FAILURE OF THE DEVICE. THEREFORE THE MOST PROBABLE ROOT CAUSE IS AN UNDETECTED PATIENT HEAD MOTION, WHICH CAN NOT BE EXPLAINED FURTHER." }, { "mdr_text_key": "91288659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE BR16005 HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. BECAUSE THE DELAY ON THE SURGERY WAS OF 30 MINUTES." }, { "mdr_text_key": "91288660", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST-OPERATIVE CT SCAN SHOWED MULTIPLE INACCURATE ELECTRODE PLACEMENTS. DURING THE SURGERY AFTER THE LASER REGISTRATION AN AN ERROR MESSAGE AWARE OF INSUFFICIENT ACCURACY AND THE SURGEON HAD TO REPEAT THE REGISTRATION THREE TIMES. DESPITE THE LAST INSTANCE OF THE ERROR MESSAGE SURGEON WAS SATISFIED WITH VERIFICATION STAGE ACCURACY AND DECIDED TO PROCEED WITH THE SURGERY." }, { "mdr_text_key": "113406612", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UPON COMPLAINT FILE REVIEW, IT WAS NOTED THAT THE INITIALLY RECORDED DEVICE MANUFACTURING DATE (24-FEB-2016) WAS INCORRECT, THE CORRECT MANUFACTURING DATE IS 08-MAR-2016." } ], "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": "05/03/2018;05/04/2018" } ] }