{ "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": "3009185973-2021-00134", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210524", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210426", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20210524", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "769278", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210524", "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": "ROSAS00204", "lot_number": "3.1.4.1652", "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": [ "Loss of Data", "Unintended Application Program Shut Down", "Loss of Data", "Unintended Application Program Shut Down" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/24/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20210524", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11869223", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210426", "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": "324841684", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "COMPANY REPRESENTATIVE (CR) WAS IN HOSPITAL TO SUPPORT A BILATERAL SEEG. SURGEON PLANED ALL 16 TRAJECTORIES FROM BRAINLAB BURNED IN ON ROSA. WHEN WE TRIED TO LOAD THE LATEST CT WITH FIDUCIALS ROSANNA CRASHED. AFTER LOADING PATIENT FOLDER 4 TRAJECTORIES WERE MISSING COMPLETELY. 1 WAS CHANGED. SURGEON REPLANNED THE 5 TRAJECTORIES AND CHECKED ALL OTHERS AS WELL. (65 MINUTES DELAY). 2 TRAJECTORIES WERE REALLY CLOSE TO MAYFIELD. CAMENBERT USED TO SOLVE ALMOST COLLISION. WHEN POSITIONED ON FIRST 3 LEFT TRAJECTORY, SURGEON USED AXIAL MODE TO POSITION. DURING THIS MONITOR WENT BLACK. 10 SECONDES. LATER MAIN MENU TO CREATE/LOAD FOLDER OR SHUT DOWN APPEARED. AFTER RELOADING FOLDER, SURGEON WANTED TO DOUBLE CHECK ACCURACY AND PLANED A TRAJECTORY ON A FIDUCIAL. ACCURACY WAS OK. REST OF PROCEDURE WENT WITHOUT ISSUES." }, { "mdr_text_key": "324841685", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE DHR AND OF THE COMPLAINT HISTORY FOR THIS DEVICE WAS PERFORMED AND DID NOT REVEAL ANY LINK WITH THE SUBJECT COMPLAINT. A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE FIRST CRASH - WHEN AN EXAM WAS LOADED FROM THE PACS - OCCURRED DUE TO A SOFTWARE ANOMALY. FOUR TRAJECTORIES WERE LOST BECAUSE THE PATIENT FOLDER HAD NOT BEEN SAVED BEFORE THE CRASH. THE FINAL ORIENTATION TOOL WAS USED FOR TWO TRAJECTORIES IN ORDER TO AVOID A COLLISION, WHICH IS A STANDARD PROCEDURE. THEN A SECOND CRASH OCCURRED DUE TO A MEMORY ALLOCATION ISSUE. THESE ISSUES WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCT. CORRECTED DATA: B4 DATE OF THIS REPORT, G3 DATE RECEIVED BY MANUFACTURER , H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, H6 ADVERSE EVENT PROBLEM, H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "252156466", "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)." }, { "mdr_text_key": "252156467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "COMPANY REPRESENTATIVE (CR) WAS IN HOSPITAL TO SUPPORT A BILATERAL SEEG. SURGEON PLANED ALL 16 TRAJECTORIES FROM BRAINLAB BURNED IN ON ROSA. WHEN WE TRIED TO LOAD THE LATEST CT WITH FIDUCIALS ROSANNA CRASHED. AFTER LOADING PATIENT FOLDER 4 TRAJECTORIES WERE MISSING COMPLETELY. 1 WAS CHANGED. SURGEON REPLANNED THE 5 TRAJECTORIES AND CHECKED ALL OTHERS AS WELL. (65 MINUTES DELAY). 2 TRAJECTORIES WERE REALLY CLOSE TO MAYFIELD. CAMENBERT USED TO SOLVE ALMOST COLLISION. WHEN POSITIONED ON FIRST 3 LEFT TRAJECTORY, SURGEON USED AXIAL MODE TO POSITION. DURING THIS MONITOR WENT BLACK. 10 SECONDES. LATER MAIN MENU TO CREATE/LOAD FOLDER OR SHUT DOWN APPEARED. AFTER RELOADING FOLDER, SURGEON WANTED TO DOUBLE CHECK ACCURACY AND PLANED A TRAJECTORY ON A FIDUCIAL. ACCURACY WAS OK. REST OF PROCEDURE WENT WITHOUT ISSUES." } ], "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": "06/25/2021" } ] }