{ "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": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2022-00030", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220509", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20220411", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "904", "date_added": "20220509", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190930", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1534942", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220509", "brand_name": "ROSA ONE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SAS", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34130", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE 3.1", "catalog_number": "ROSAS00215", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/01/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9047", "patient": [ { "patient_sequence_number": "1", "date_received": "20220509", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Neuropathy", "Hematoma", "Neuropathy" ] } ], "distributor_city": "", "date_report": "20220902", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "14336203", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220411", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTECH SAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "291200792", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UDI#: (B)(4)." }, { "mdr_text_key": "291200793", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A BRAIN SURGERY WAS PERFORMED WITH ROSA ONE BRAIN ON (B)(6) 2022. IN SEEG ELECTRODE PLACEMENT, SUBDURAL HEMATOMA WAS FOUND BY POSTOPERATIVE CT. POSTOPERATIVE ANESTHESIA AFTER AWAKENING, PARALYSIS WAS CONFIRMED IN THE GRIP STRENGTH AND BEHAVIOR OF THE LEFT FINGERTIP. ABOUT FOUR HOURS AFTER THE SURGERY, THE CONDITION WAS IMPROVED BUT IT WAS RECOGNIZED AS NEUROPATHY. THE CAUSAL RELATIONSHIP WITH THE SITE OF SUBDURAL HEMATOMA IS UNKNOWN. IF PARALYSIS REMAINS, THE ELECTRODE MAY BE REMOVED. THERE WAS NO PROBLEM WITH THE OPERATION OF ROSA DURING THE OPERATION, AND THE CAUSAL RELATIONSHIP WITH THIS COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "331779630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO IDENTIFIED THAT THE PATTERN OF AUTOMATIC SCAN ON PATIENT¿S FOREHEAD ¿ WHICH AREA IS USED FOR THE IDENTIFICATION SAMPLE - WAS TOO SMALL IN RELATION TO THE AVAILABLE AREA. THEREFORE, THE REGISTRATION RESULT WAS CORRECT BUT NOT OPTIMAL. IT WAS CONFIRMED THAT THREE ELECTRODES AMONG SEVEN WERE IMPLANTED OVER THE SPECIFICATION LIMIT OF 2 MM AT THE ENTRY POINT. THE DEVIATION OF ELECTRODES SHOWS THAT A ROTATION OF THE HEAD COULD BE THE CAUSE BUT THIS ASSUMPTION CANNOT BE CONFIRMED. THE ELECTRODE RESPONSIBLE FOR THE SUBDURAL HEMATOMA AND THE PATIENT NEUROPATHY ¿ ACCORDING TO THE MEDICAL TEAM - WAS IMPLANTED ACCURATELY IN RELATION TO THE REGISTERED EXAM. ON THIS PARTICULAR TRAJECTORY, THE ROBOT OPERATED AS EXPECTED. ACCORDING TO HEALTH CARE PROFESSIONAL REVIEW, THE HEMORRHAGE IS UNLIKELY DUE TO THE ROBOT USE AND COULD COME FROM ANOTHER ELECTRODE WHICH WAS IMPLANTED SHIFTED. THE CAUSE FOR THE SHIFT COULD BE EXPLAIN BY OTHER FACTORS WHICH CANNOT BE CONFIRMED BY ANALYSIS. THE DHR REVIEW SHOWED THAT DEVICE PASSED THE LAST MAINTENANCE. NO ROBOTIC ERROR WAS FOUND." }, { "mdr_text_key": "331779631", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A BRAIN SURGERY WAS PERFORMED WITH ROSA ONE BRAIN ON (B)(6) 2022. IN SEEG ELECTRODE PLACEMENT, SUBDURAL HEMATOMA WAS FOUND BY POSTOPERATIVE CT. POSTOPERATIVE ANESTHESIA AFTER AWAKENING, PARALYSIS WAS CONFIRMED IN THE GRIP STRENGTH AND BEHAVIOR OF THE LEFT FINGERTIP. ABOUT FOUR HOURS AFTER THE SURGERY, THE CONDITION WAS IMPROVED BUT IT WAS RECOGNIZED AS NEUROPATHY. THE CAUSAL RELATIONSHIP WITH THE SITE OF SUBDURAL HEMATOMA IS UNKNOWN. IF PARALYSIS REMAINS, THE ELECTRODE MAY BE REMOVED. THERE WAS NO PROBLEM WITH THE OPERATION OF ROSA DURING THE OPERATION, AND THE CAUSAL RELATIONSHIP WITH THIS COMPLICATION IS UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/08/2022" } ] }