{ "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": "3009185973-2022-00024", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220411", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20220314", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "003", "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": "FR", "manufacturer_contact_area_code": "904", "date_added": "20220411", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20160621", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1900477", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220411", "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": "ROSAS00201", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "", "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": "20220411", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Dysphasia", "Speech Disorder", "Hemorrhage/Blood Loss/Bleeding", "Dysphasia", "Speech Disorder" ] } ], "distributor_city": "", "date_report": "20220411", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "14073767", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220314", "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": "288991303", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT PRESENTED A TEMPORAL HEMORRHAGE WITH READING AND NAMING DIFFICULTIES. DURING THE SURGERY, THE FUSION WAS GOOD, AS WELL AS THE PATIENT'S POSITION. THE HEAD HOLDER WAS STABLE. THE REGISTRATION COULD HAVE BEEN BETTER DONE (LASER POINTS INSTEAD OF LINES) BUT THE REGISTRATION VALUES WERE ALL GOOD (GREEN)." }, { "mdr_text_key": "288991304", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UNIQUE IDENTIFIER (UDI) #: (B)(4). A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT ALL TEN TRAJECTORIES WERE IMPLANTED INACCURATELY REGARDING THE SPECIFICATIONS, WHICH COULD BE A CAUSE FOR THE HEMORRHAGE. A GLOBAL TREND OF CAUDAL DEVIATION WAS FOUND AND THE MOST ANTERIOR ELECTRODES WERE ALSO DEVIATED SLIGHTLY FORWARD WHICH COULD INDICATE A ROTATION OF THE HEAD IN RELATION TO THE REGISTRATION PERFORMED. THE DEVIATION ANALYSIS ALSO INDICATES THAT MULTIPLE ELECTRODES WERE IMPLANTED TWISTED OR BIAS. THE CURVATURE OF THE ELECTRODE INSIDE THE BRAIN DEPENDS ON VARIOUS FACTORS, INCLUDING,BUT NOT LIMITED TO, THE MATERIAL OF THE ELECTRODE, ITS STIFFNESS, THE PATIENT ANATOMY AND/OR THE METHOD OF IMPLANTATION. IN THIS CASE, FOR MOST OF THEM, THE ELECTRODES SHIFT AT THE ENTRY POINTS ALSO CONTRIBUTED TO THE TARGET POINT ERROR. HOWEVER, NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED. NO DEVICE FAILURE WAS DETECTED. THE DEVICE PASSED THE MAINTENANCES PERFORMED BEFORE AND AFTER THE EVENT. ALTHOUGH THAT THE REGISTRATION COULD HAVE BEEN OPTIMIZED, THE DATA OF ANALYSIS SHOWS THAT IT WAS PROPERLY EXECUTED." } ], "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": "" } ] }