{ "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": "3009185973-2017-00260", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170403", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20150415", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170403", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "235980", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170403", "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 2.5.8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20170403", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20170327", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6453336", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150415", "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": "71526723", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE RO 14 031 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT SOME OF THE IMPLANTED ELECTRODES WERE SHALLOW BUT IT WAS NOT RELATED TO THE ROSA BUT TO THE SURGEON'S IMPLANTATION TECHNIQUE. THE SURGEON AGREED THAT THE ISSUE PROBABLY OCCURRED DUE TO INSUFFICIENT TRAINING OF THE OPERATOR. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4)." }, { "mdr_text_key": "71526724", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A SEEG PROCEDURE IT HAS BEEN REPORTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT FRONTOPARIETAL HEMORRHAGE. A VERY SIGNIFICANT DISCREPANCY WAS NOTICED IN ALL OF THE ELECTRODES, WITH A >5MM INFERIOR ERROR. THIS WAS IRRESPECTIVE OF SIDE. ADDITIONALLY, THE ELECTRODES ON THE RIGHT WERE ALL TOO SHALLOW. WHILE BRAIN SHIFT ON THE POST OP SCAN CAN ACCOUNT FOR SOME OF THE APPARENT ERROR THERE IS NOT QUESTION IT DOES NOT ACCOUNT FOR ALL OF IT, IN PARTICULAR THE PROBLEMS WITH THE MESIAL TEMPORAL ONES. AS A RESULT, WE HAVE A HEMORRHAGE, WHICH OF COURSE MAY OR MAY NOT BE DUE TO THIS, AND MISSED THE HIPPOCAMPUS ON ALL ELECTRODES ON ONE SIDE NECESSITATING A SUBSEQUENT PROCEDURE. THE SURGEON NOTICED THAT HE MISSED THE HIPPOCAMPUS ON ALL ELECTRODES ON ONE SIDE NECESSITATING A SUBSEQUENT PROCEDURE." } ], "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": "" } ] }