{ "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": "3009185973-2018-00268", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181015", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180918", "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": "SP", "manufacturer_contact_area_code": "", "date_added": "20181015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "808539", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181015", "brand_name": "ROSA SURGICAL DEVICE", "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", "catalog_number": "N/A", "lot_number": "2.5.8.4", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/19/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20181015", "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": "20190117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7964256", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181002", "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": "123671008", "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." }, { "mdr_text_key": "123671029", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 2ND OCTOBER, DR (B)(6) (NEUROLOGIST) CALLED MEDTECH CUSTOMER SERVICE TO INFORM THAT DURING LAST SURGERY ON THE (B)(6) 2018, A BLEEDING APPEARED AT THE POST-OP CONTROL. THE SURGERY CASE WAS A SEEG AND WAS DONE BY DR (B)(6)." }, { "mdr_text_key": "312101093", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 2ND OCTOBER, DR ROCAMORA (NEUROLOGIST) CALLED MEDTECH CUSTOMER SERVICE TO INFORM THAT DURING LAST SURGERY ON THE (B)(6)-2018, A BLEEDING APPEARED AT THE POST-OP CONTROL. THE SURGERY CASE WAS A SEEG AND WAS DONE BY DR SERRANO." }, { "mdr_text_key": "312101094", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. REVIEW OF COMPLAINT HISTORY SHOWED THAT ANOTHER HAEMORRHAGE OCCURRED PREVIOUSELY DURING A SURGERY WITH THE SAME DEVICE, CAUSED BY A USER ERROR. ACCORDING TO THE TECHNICAL INVESTIGATION THE ELECTRODES HAVE BEEN INSERTED WITH ACCURACY, HOWEVER THEY ARE ALL CURVED INSIDE THE BRAIN WHICH COULD BE THE CAUSE FOR THE HEMORRHAGE. THE QUALITY OF ELECTRODES, THEIR SHAPE BEFORE TO BE INSERTED, THE IMPLANTATION METHOD AND THE PATIENT ANATOMY CAN BE CONTRIBUTING FACTORS BUT THOSE ARE NOT LINKED TO THE ROSA DEVICE PERFORMANCE. IT WAS ALSO, THE VERIFICATION STEP OF THE BONE FIDUCIAL REGISTRATION WAS NOT EXECUTED ACCORDING TO THE IFU RECOMMENDATION BUT IT DID NOT IMPACT THE ACCURACY OF ELECTRODES PLACEMENT AT THE ENTRY POINTS. THE DEVICE WORKED AS INTENDED DURING THE SURGERY. IT WAS NOTED THAT THE SURGEON WHO WAS OPERATING THE DEVICE WAS NOT TRAINED TO USE THE DEVICE BY MEDTECH." } ], "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": "01/18/2019" } ] }