{ "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": "3009185973-2017-00058", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170320", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20150218", "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": "20170320", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "200212", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170320", "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": [ "Positioning Problem" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20170320", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "52 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Complaint, Ill-Defined", "Complaint, Ill-Defined" ] } ], "distributor_city": "", "date_report": "20170315", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6417448", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150218", "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": "70355681", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE RO 14 038HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT A NOT DETECTED SHIFT BETWEEN THE INFORMATION DISPLAYED IN THE NAVIGATION SOFTWARE AND THE ACTUAL PATIENT ANATOMY, POTENTIALLY CAUSED BY HEAD MOTION INSIDE THE HEAD HOLDER DUE TO HIGH THICKNESS OF THE PATIENT'S SKIN AND HANDLING OF THE PATIENT HEAD DURING SURGERY. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4)." }, { "mdr_text_key": "70355682", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT HAS BEEN REPORTED THAT THE SURGEON MERGED THE POST-OP CT IMAGE AND FOUND THAT ON ALL BUT ONE TRAJECTORY, THERE WAS A SIGNIFICANT DISCREPANCY IN THE PLAN AND IN THE TRUE POSITION OF ELECTRODES. THERE APPEARS TO BE, ACCORDING TO THE SURGEON, A CONSISTENT 5MM CEPHALAD ENTRY POINT CONSISTENT WITH THE PLAN. ELECTRODES, ACCORDING TO THE SURGEON, APPEAR TO BE PARALLEL TO THE PLAN AND THE TARGET POINTS DIFFER AS WELL. ONE ELECTRODE IS INFERIOR TO PLAN. THE SURGEON IS REQUESTING SUPPORT TO ANALYZE THE REASON FOR PLACEMENT RESULTS AND DOES NOT PLANNING ON REPLACING ELECTRODES AT THIS TIME. AFTER OPERATION PATIENT IS \"VERY DYSARTHRIC.\" PATIENT HAS EXPERIENCED A STROKE PRIOR TO THIS OPERATION. NO SEIZURES HAVE YET BEEN RECORDED IN THE EMU FOLLOWING SURGERY, SO NO EPILEPTIFORM ACTIVITY HAS BEEN OBSERVED IN THE DEPTH ELECTRODES." } ], "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": "" } ] }