{ "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": "MAUGIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2021-00187", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211222", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20211122", "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": "FR", "manufacturer_contact_area_code": "904", "date_added": "20211222", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200916", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1966480", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20211222", "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", "catalog_number": "ROSAS00201", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/18/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "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": "20211222", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage", "Movement Disorder", "Speech Disorder", "Intracranial Hemorrhage", "Movement Disorder", "Speech Disorder" ] } ], "distributor_city": "", "date_report": "20220127", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "13058933", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211202", "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": "282605271", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIAL REPORT : 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": "282605272", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A SYMPTOMATIC BLEEDING COMPLICATION WAS REPORTED ON A TRAJECTORY DEVIATION AT THE ENTRY POINT FOR THE FCA' TRAJECTORY." }, { "mdr_text_key": "327528076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A SYMPTOMATIC BLEEDING COMPLICATION WAS REPORTED ON A TRAJECTORY DEVIATION AT THE ENTRY POINT FOR THE FCA' TRAJECTORY." }, { "mdr_text_key": "327528077", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ANALYSIS OF THE DEVICE DATA LOGS AND OF THE PATIENT FILE WAS PERFORMED. THIS ANALYSIS CONCLUDED THAT THE INACCURACY AT THE ENTRY POINT IS CONFIRMED FOR ALL THE FIFTEEN TRAJECTORIES IMPLANTED. ELEVEN ELECTRODES WERE IMPLANTED FURTHER THAN EXPECTED. NO ROBOTIC OR FUNCTIONAL ERROR WAS FOUND AND THE ELEMENTS OF ANALYSIS INDICATE THAT THE DEVICE BEHAVED AS EXPECTED. NOTE THAT THE ELECTRODE DEPTH INSIDE THE BRAIN DEPENDS ON THE METHOD OF IMPLANTATION. THE DEVIATION ANALYSIS SHOWS THAT ALL ELECTRODES ARE DEVIATED IN THE SAME DIRECTION AND COULD BE THE RESULT OF AN UNEXPECTED MOVEMENT OF THE PATIENT'S HEAD AFTER THE REGISTRATION. THE LASER REGISTRATION RESULTS ARE CORRECT BUT NOT OPTIMAL. AS THE ENTRY POINTS WERE NOT CHECKED WITH THE LASER PRIOR TO NAVIGATION WITH THE INSTRUMENT HOLDER, A POTENTIAL MOVEMENT OF THE HEAD COULD HAVE REMAINED UNNOTICED. THE REGISTRATION RESULTS WERE NOT OPTIMAL POSSIBLY DUE TO THE REFERENCE EXAM USED (1.5T MRI). A REVIEW OF THE IFU CONFIRMED THAT RECOMMENDATIONS ARE ADEQUATELY PROVIDED TO UNDERLINE THE IMPORTANCE OF THE 3D EXAM REFERENCE CHOICE AND QUALITY TO ENSURE THE ACCURACY OF THE REGISTRATION. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS 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": "01/27/2022" } ] }