{ "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": "3009185973-2021-00024", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210126", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210111", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20210126", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "125310", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210126", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00209", "lot_number": "3.1.4.1650", "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": [ "Difficult or Delayed Activation", "Difficult or Delayed Activation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/09/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20210126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Clinical Signs, Symptoms or Conditions", "No Code Available", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210407", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11229184", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210111", "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": "323620073", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO CONCLUDE THAT THE MOVE TO THE PREDEFINED HOME POSITION FROM PARKING FAILED AFTER THE ARM CONNECTION MULTIPLE TIMES, INCLUDING FROM THE MAINTENANCE KINEVERIF SOFTWARE. THIS ISSUE WAS DUE TO THE VIGILANCE DEVICE PLUGS INCORRECT CONNECTION. THE ADJUSTMENT OF PINS INSIDE THE PLUG PERMITTED TO SOLVE THE ISSUE. EACH CABLES AND ALSO ALL WELDS OF THE VIGILANCE DEVICE WERE CHECKED AND WERE ALL FUNCTIONAL." }, { "mdr_text_key": "323620074", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON INFORMED, AND REPORTED AT STARTING UP THE SYSTEM, ROSA SAYS THE ARM IS NOT FREE. BEFORE THAT HAPPENS THE SYSTEM WAS NORMALLY SHUT DOWN. THE SURGEON HAD PUSH EMERGENCY BUTTON AND IN MAINTENANCE MODE SHE WAS ABLE TO MOVE THE ROSA ARM. IN THEATRE/PATIENT UNDER ANESTHESIA/BEFORE SURGERY PROCEDURE AND INCISION DELAY IN MINUTES: 35, SYSTEM HAD RESTARTED MULTIPLE TIMES, TO START PROCEDURE." }, { "mdr_text_key": "228645851", "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. UNIQUE IDENTIFIER (UDI) #: (B)(4). PATIENT CODE (B)(4) WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT." }, { "mdr_text_key": "228645852", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON INFORMED, AND REPORTED AT STARTING UP THE SYSTEM, ROSA SAYS THE ARM IS NOT FREE. BEFORE THAT HAPPENS THE SYSTEM WAS NORMALLY SHUT DOWN. THE SURGEON HAD PUSH EMERGENCY BUTTON AND IN MAINTENANCE MODE SHE WAS ABLE TO MOVE THE ROSA ARM. IN THEATRE / PATIENT UNDER ANESTHESIA / BEFORE SURGERY PROCEDURE AND INCISION DELAY IN MINUTES: 35, SYSTEM HAD RESTARTED MULTIPLE TIMES, TO START 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": "04/07/2021" } ] }