{ "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": "3009185973-2019-00441", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20191212", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191113", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "20191212", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1256701", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191212", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "ROSAS00303", "lot_number": "3.0.0.21", "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": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/19/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20191212", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200327", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9457234", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191113", "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": "316587487", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) TOLD THE SURGEON THAT THE CTA MAY NOT BE USABLE FOR LASER REGISTRATION. THE FSE NOTICED THAT THE PATIENT'S FACE WAS NOT KEPT CLEAR FOR THE SCAN. THERE WAS A BELT HOLDING THE PATIENT DOWN ON THEIR FOREHEAD, AND WHAT APPEARED TO BE BLANKETS AROUND THEIR HEAD, POSSIBLY COMPRESSING THE HEAD AROUND THE TEMPLES AND OTHER AREAS. THE SURGEON WANTED TO TRY AND USE THE SCAN FOR LASER REGISTRATION. AROUND 10:10AM EST, THE FIRST LASER REGISTRATION WAS ATTEMPTED, BUT AN ERROR MESSAGE WAS EXPERIENCED. AFTER PERFORMING THE VERIFICATION, IT WAS DETERMINED THAT THE REGISTRATION WAS NOT ACCURATE. AFTER PERFORMING A SECOND AND THIRD LASER REGISTRATION, IT WAS DETERMINED THAT THE CURRENT SCAN WAS NOT WORKING, AND THAT A NEW SCAN WAS TO BE OBTAINED WITH BONE FIDUCIALS. AFTER THE NEW SCAN WAS OBTAINED AND UPLOADED/MERGED, THE BONE FIDUCIAL REGISTRATION WAS PERFORMED, AND THE SURGEON ACCEPTED THE RMS OF 0.99MM AND APPROVED OF THE VERIFICATION OF THE REGISTRATION. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE. PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. TOTAL DELAY WAS OVER AN HOUR DUE TO THE NUMEROUS LASER REGISTRATIONS AND OBTAINING A NEW PATIENT SCAN WITH BONE FIDUCIALS." }, { "mdr_text_key": "316587488", "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. ANALYSIS OF THE SOFTWARE LOGS CONCLUDED THAT THE EVENT OCCURRED BECAUSE THE CT SCAN WAS ACQUIRED WHILE A BELT AND BLANKETS WERE POSITION ON AND AROUND THE PATIENT HEAD TO MAINTAIN IT. AS INDICATED IN THE ACQUISITION PROTOCOL AND THE USER MANUAL, SKIN DEFORMATION HAS TO BE AVOIDED WHEN IMAGERIES ARE ACQUIRED THEREFORE, THE EVENT DESCRIBED IN THE COMPLAINT DESCRIPTION CAN BE CONSIDERED AS A USE ERROR. CORRECTED DATA: B4 DATE OF THIS REPORT. G4 DATE RECEIVED BY MANUFACTURER. H2 IF FOLLOW-UP, WHAT TYPE. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "171607831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "171607832", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) TOLD THE SURGEON THAT THE CTA MAY NOT BE USABLE FOR LASER REGISTRATION. THE FSE NOTICED THAT THE PATIENT'S FACE WAS NOT KEPT CLEAR FOR THE SCAN. THERE WAS A BELT HOLDING THE PATIENT DOWN ON THEIR FOREHEAD, AND WHAT APPEARED TO BE BLANKETS AROUND THEIR HEAD, POSSIBLY COMPRESSING THE HEAD AROUND THE TEMPLES AND OTHER AREAS. THE SURGEON WANTED TO TRY AND USE THE SCAN FOR LASER REGISTRATION. AROUND 10:10AM EST, THE FIRST LASER REGISTRATION WAS ATTEMPTED, BUT AN ERROR MESSAGE WAS EXPERIENCED. AFTER PERFORMING THE VERIFICATION, IT WAS DETERMINED THAT THE REGISTRATION WAS NOT ACCURATE. AFTER PERFORMING A SECOND AND THIRD LASER REGISTRATION, IT WAS DETERMINED THAT THE CURRENT SCAN WAS NOT WORKING, AND THAT A NEW SCAN WAS TO BE OBTAINED WITH BONE FIDUCIALS. AFTER THE NEW SCAN WAS OBTAINED AND UPLOADED/MERGED, THE BONE FIDUCIAL REGISTRATION WAS PERFORMED, AND THE SURGEON ACCEPTED THE RMS OF 0.99MM AND APPROVED OF THE VERIFICATION OF THE REGISTRATION. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE. PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. TOTAL DELAY WAS OVER AN HOUR DUE TO THE NUMEROUS LASER REGISTRATIONS AND OBTAINING A NEW PATIENT SCAN WITH BONE FIDUCIALS." } ], "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": "03/27/2020" } ] }