{ "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": "3009185973-2018-00251", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180925", "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": "FR", "manufacturer_contact_area_code": "", "date_added": "20180925", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "747609", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180925", "brand_name": "ROSA", "generic_name": "COMPUTER-ASSISTED SURGIVAL 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": "ROSA", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/24/2019", "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": "20180925", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20190430", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7904701", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180920", "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": "286993843", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SOME ELECTRODES WERE POSITIONED INACCURATELY, WHICH WAS CONFIRMED DURING TECHNICAL INVESTIGATION. THE ERROR IS HOMOGENOUS WHICH INDICATES THAT IT WAS DUE TO THE SAME GLOBAL MOVEMENT. THE PRE-OPERATIVE FUSION ANALYSIS SHOWS THAT IMAGES WERE SLIGHTLY SHIFTED. IT SEEMS THAT THE INACCURACY IS DIRECTLY RELATED TO THIS INCORRECT FUSION, THIS ISSUE CAN BE CONSIDERED AS A USE ERROR. THE DEVICE PRECISION WAS TESTED A FEW DAYS AFTER THE SURGERY AND WAS FOUND IN CONFORMANCE." }, { "mdr_text_key": "286993844", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON CALLED THE FIELD SERVICE ENGINEER ON 20 SEP 2018 TO INFORM THAT SHE NOTICED SOME ELECTRODES IMPLANTED ON (B)(6) 2018 WERE MISPLACED. THE SURGEON STATED THAT THE TEMPORAL ELECTRODES WERE SHIFTED 4-5MM ON CORONAL PLAN. SHE ALSO STATED THE SURGERY WENT FINE: LASER REGISTRATION PASSED ON THE FIRST TIME, NO CORRECTIONS, VERIFICATION PASSED AND PATIENT INSTALLATION CHECKED. A FIELD SERVICE ENGINEER WAS ON SITE ON (B)(6)2018 TO PERFORM KINEVERIF TESTS (LASER, POINTER) AS WELL AS APPLICATIVE TEST, WHICH BOTH PASSED. THE SURGEON CONFIRMED THE PATIENT WAS DOING FINE." }, { "mdr_text_key": "121562103", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "121562104", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED THE FIELD SERVICE ENGINEER ON (B)(6) 2018 TO INFORM THAT SHE NOTICED SOME ELECTRODES IMPLANTED ON (B)(6) 2018 WERE MISPLACED. THE SURGEON STATED THAT THE TEMPORAL ELECTRODES WERE SHIFTED 4-5MM ON CORONAL PLAN. SHE ALSO STATED THE SURGERY WENT FINE: LASER REGISTRATION PASSED ON THE FIRST TIME, NO CORRECTIONS, VERIFICATION PASSED AND PATIENT INSTALLATION CHECKED. A FIELD SERVICE ENGINEER WAS ON SITE ON (B)(6) 2018 TO PERFORM KINEVERIF TESTS (LASER, POINTER) AS WELL AS APPLICATIVE TEST, WHICH BOTH PASSED. THE SURGEON CONFIRMED THE PATIENT WAS DOING FINE." } ], "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": "05/02/2019" } ] }