{ "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": "3009185973-2018-00011", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180112", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20171214", "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": "20180112", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "31323", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180112", "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": "N/A", "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/24/2018", "mfr_report_type": "", "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": "20180112", "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": "20180125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7185615", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20171214", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace", "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": "97079551", "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. (B)(4)." }, { "mdr_text_key": "97079552", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT WHILE TRYING TO REGISTER A PATIENT, WITH MARKERS, THE SYSTEM HAD A COMMUNICATION FAILURE. IT WAS NOTICED THAT THE CABLE TO THE FORCE SENSOR WAS ALMOST COMPLETELY DISCONNECTED. THE SURGERY WAS ABORTED." }, { "mdr_text_key": "271520917", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE VISUAL INSPECTION OF THE INTERFACE BLOCK CONFIRMED THAT IT WAS DAMAGED AND THAT THE ISSUE CAME FROM THE LENGTH OF THE FORCE SENSOR CABLE THAT IS TOO SHORT. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE IF THIS CABLE WAS INCORRECTLY SET DURING THE REPLACEMENT BY A FIELD SERVICE TECHNICIAN OR IF IT WAS INCORRECTLY SET AFTER REPLACEMENT. THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: DATE OF THIS REPORT, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE, REMEDIAL ACTION, DATE RECEIVED BY MANUFACTURER, REPORTER NAME AND ADDRESS." } ], "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": "01/25/2018" } ] }