{ "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": "3009185973-2019-00154", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190430", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190402", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20190430", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "357393", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190430", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/07/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20190430", "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": "20200504", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8565444", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190402", "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": "316149566", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE VERIFICATION STEP OF THE REGISTRATION, IT WAS NOTED THAT THE TEMPLES ON THE SCAN LOOKED TOO DEEP IN THE SKIN. UPON EXAMINATION OF THE CT, IT APPEARED THAT THE PATIENT WAS WEARING GLASSES WHILE THE SCAN WAS TAKEN DUE TO AN INDENT ON THE SKIN. A COUPLE OF THE TRAJECTORIES WERE ALONG THIS LINE; HOWEVER, THE SURGEON DEBATED IF THE REGISTRATION COULD STILL BE USED. UPON CHECKING THE ENTRY POINT OF OTHER TRAJECTORIES, IT WAS SEEN THAT THE CROSSHAIR OF THE LASER LOOKED PERFECTLY ON THE SKIN FOR SOME, BUT WAS OFF FOR OTHERS. THE REGISTRATION WAS CANCELLED AND RE-PERFORMED. THIS CAUSED A DELAY OF ABOUT 30 MINUTES TO THE SURGERY. DURING THE TEMPLE SCAN OF THE SECOND REGISTRATION THE AREA WHERE THE PATIENT WAS WEARING GLASSES WAS AVOIDED. THE VERIFICATION OF THE SECOND REGISTRATION WAS ACCEPTABLE AND BETTER THAN THE FIRST." }, { "mdr_text_key": "316149567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THAT THE TEMPLES ON THE SCAN LOOKED TOO DEEP IN THE SKIN DURING THE REGISTRATION VERIFICATION. THE DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE LOG FILES AND SCREENSHOTS OF THE VERIFICATION STEP OF THE REGISTRATION ARE NOT AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS EVENT OCCURRED AS THE PATIENT WAS WEARING GLASSES WHEN THE CT SCAN WAS ACQUIRED. AS INDICATED IN THE IFU, SKIN DEFORMATION HAS TO BE AVOIDED WHEN IMAGERIES ARE ACQUIRED. THEREFORE, THE EVENT DESCRIBED IN THE COMPLAINT DESCRIPTION CANNOT BE CONSIDERED AS A SOFTWARE ISSUE BUT IT CAN BE CONSIDERED AS A USE ERROR. ACCORDING TO THE COMPLAINT DESCRIPTION THE SURGEON DECIDED TO CANCEL THE FIRST REGISTRATION TO DO A NEW ONE, AND AVOIDING THE GLASSES AREA SOLVED THE ISSUE." }, { "mdr_text_key": "143580882", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "143580883", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING THE VERIFICATION STEP OF THE REGISTRATION, IT WAS NOTED THAT THE TEMPLES ON THE SCAN LOOKED TOO DEEP IN THE SKIN. UPON EXAMINATION OF THE CT, IT APPEARED THAT THE PATIENT WAS WEARING GLASSES WHILE THE SCAN WAS TAKEN DUE TO AN INDENT ON THE SKIN. A COUPLE OF THE TRAJECTORIES WERE ALONG THIS LINE; HOWEVER, THE SURGEON DEBATED IF THE REGISTRATION COULD STILL BE USED. UPON CHECKING THE ENTRY POINT OF OTHER TRAJECTORIES, IT WAS SEEN THAT THE CROSSHAIR OF THE LASER LOOKED PERFECTLY ON THE SKIN FOR SOME, BUT WAS OFF FOR OTHERS. THE REGISTRATION WAS CANCELLED AND RE-PERFORMED. THIS CAUSED A DELAY OF ABOUT 30 MINUTES TO THE SURGERY. DURING THE TEMPLE SCAN OF THE SECOND REGISTRATION THE AREA WHERE THE PATIENT WAS WEARING GLASSES WAS AVOIDED. THE VERIFICATION OF THE SECOND REGISTRATION WAS ACCEPTABLE AND BETTER THAN THE FIRST." } ], "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": "05/04/2020" } ] }