{ "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": "3009185973-2022-00036", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220726", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20220718", "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": "US", "manufacturer_contact_area_code": "904", "date_added": "20220726", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20201221", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1369498", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220726", "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": "ROSAS00203", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/01/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20220726", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220906", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "15102244", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220718", "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": "296569164", "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": "296569165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CT SCAN TAKEN AFTER AN SEEG PROCEDURE SHOWED THAT THE PATIENT HAD A HEMORRHAGE. SURGEON PROCEEDED WITH A CRANIOTOMY AND WAS ABLE TO STOP THE BLEEDING. FIELD SERVICE ENGINEER MERGED THE CT TO THE PATIENT¿S PLAN AND NOTED THAT SEVERAL TRAJECTORIES WERE DEVIATED AND CURVED." }, { "mdr_text_key": "331728279", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CT SCAN TAKEN AFTER AN SEEG PROCEDURE SHOWED THAT THE PATIENT HAD A HEMORRHAGE. SURGEON PROCEEDED WITH A CRANIOTOMY AND WAS ABLE TO STOP THE BLEEDING. FIELD SERVICE ENGINEER MERGED THE CT TO THE PATIENT¿S PLAN AND NOTED THAT SEVERAL TRAJECTORIES WERE DEVIATED AND CURVED." }, { "mdr_text_key": "331728280", "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 CONCLUDED THAT THE INACCURACY OF THE ELECTRODES PLACEMENT REGARDING THE PLAN IS CONFIRMED AND IS LIKELY DUE TO THE INCORRECT FUSION OF PRE-OPERATIVE EXAMS. INDEED, THE AUTOMATIC FUSION DID NOT PROVIDE A CORRECT RESULT AND IT WAS NOT RE-ADJUSTED BY USER AS RECOMMENDED IN THE USER MANUAL. THIS ERROR COULD CONTRIBUTE TO THE HEMORRHAGE. ALTHOUGH THE DEVICE BEHAVED AS EXPECTED ¿ THE INCORRECT AUTOMATIC FUSION RESULT CAN BE RELATED TO A PERFORMANCE ISSUE THAT WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. REGISTRATION: THE VERIFICATION RESULTS PROVIDED INCORRECT OUTPUTS DUE TO THAT THE 3D SEGMENTATION WAS NOT REWORKED PROPERLY BY USER. 2D VIEWS SHOW ACCURATE REGISTRATION RESULTS. THE MOUNTING USED TO PLACE MARKERS IS OFF-LABEL. NEVERTHELESS, 11/13 ELECTRODES PLACEMENT REGARDING THE REGISTERED WERE ACCURATELY PLACED. BOTH SHIFTS OBSERVED ARE NOT ON THE HEMORRHAGE SIDE, INFERIOR TO 2.6 MM, SLIGHTLY FORWARD BUT DO NOT HAVE THE SAME ORIENTATION. THOSE ELEMENTS SHOW THAT THE ERROR IS UNLIKELY DUE TO A ROBOTIC ERROR. HOWEVER, THE CAUSE CANNOT BE CONFIRMED." } ], "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" } ] }