{ "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": "3009185973-2019-00269", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190821", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190722", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "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": "20190821", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "711004", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190821", "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": "N/A", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/08/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20190821", "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": "20191114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8916675", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190722", "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": "155097007", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (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": "155097008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "LASER REGISTRATION WAS PERFORMED THREE TIMES, BECAUSE THE FIRST TWO REGISTRATIONS DID NOT SHOW GOOD ACCURACY IN THE VERIFICATION STEP. DURING THE FIRST REGISTRATION, THE SURGEON ACCIDENTALLY PLACED HIS FINGER IN FRONT OF THE LASER DURING THE RIGHT SIDE OF THE NOSE SCAN. THERE WAS NO ERROR MESSAGE AFTER THE REGISTRATION WAS PERFORMED; HOWEVER, THE CROSS-HAIR WITHIN THE CIRCLE ON THE NASEON AND OUTER CANTHUS POINTS LOOKED SLIGHTLY DEEP WHILE IT LOOKED SHALLOW ON THE TEMPLES. THE REGISTRATION WAS CANCELLED AND THE 3D MODEL WAS RESTRUCTURED BEFORE TRYING AGAIN. THE SECOND REGISTRATION AGAIN DID NOT SHOW ANY ERROR MESSAGE; HOWEVER, THE VERIFICATION WAS THE SAME. REGISTRATION WAS ATTEMPTED A THIRD TIME. THE 3D MODEL WAS RECONSTRUCTED AGAIN AND THE FOREHEAD POINTS WERE REDEFINED TO AVOID ANY DEFORMATION OF THE SKIN FROM THE LEKSELL PINS. THE NOSE AND TEMPLE SCANS WERE PERFORMED ON THE BONY PARTS OF THE ANATOMY. VERIFICATION OF THIS FINAL REGISTRATION LOOKED GOOD. THE DELAY WAS AN HOUR AND 20 MINUTES." }, { "mdr_text_key": "312108798", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTIES TO PERFORM THE REGISTRATION OF THE PATIENT. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE REGISTRATION WAS PERFORMED CORRECTLY AND THERE WAS NO FAILURE OF THE DEVICE.THE USER DECIDED TO RESTART THE REGISTRATION TO IMPROVE THE RESULTS AND RESPECTED THE INSTRUCTIONS OF THE IFU." }, { "mdr_text_key": "312108799", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "LASER REGISTRATION WAS PERFORMED THREE TIMES, BECAUSE THE FIRST TWO REGISTRATIONS DID NOT SHOW GOOD ACCURACY IN THE VERIFICATION STEP. DURING THE FIRST REGISTRATION, THE SURGEON ACCIDENTALLY PLACED HIS FINGER IN FRONT OF THE LASER DURING THE RIGHT SIDE OF THE NOSE SCAN. THERE WAS NO ERROR MESSAGE AFTER THE REGISTRATION WAS PERFORMED; HOWEVER, THE CROSS-HAIR WITHIN THE CIRCLE ON THE NASEON AND OUTER CANTHUS POINTS LOOKED SLIGHTLY DEEP WHILE IT LOOKED SHALLOW ON THE TEMPLES.THE REGISTRATION WAS CANCELLED AND THE 3D MODEL WAS RESTRUCTURED BEFORE TRYING AGAIN. THE SECOND REGISTRATION AGAIN DID NOT SHOW ANY ERROR MESSAGE; HOWEVER, THE VERIFICATION WAS THE SAME. REGISTRATION WAS ATTEMPTED A THIRD TIME. THE 3D MODEL WAS RECONSTRUCTED AGAIN AND THE FOREHEAD POINTS WERE REDEFINED TO AVOID ANY DEFORMATION OF THE SKIN FROM THE LEKSELL PINS. THE NOSE AND TEMPLE SCANS WEREPERFORMED ON THE BONY PARTS OF THE ANATOMY. VERIFICATION OF THIS FINAL REGISTRATION LOOKED GOOD. THE DELAY WAS AN HOUR AND 20 MINUTES." } ], "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": "11/14/2019" } ] }