{ "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": "3009185973-2018-00342", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20181220", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181120", "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": "20181220", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1027077", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181220", "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": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/18/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20181220", "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": "20190319", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8183495", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181120", "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": "130981624", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(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": "130981625", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2018 AT (B)(6) WITH DR. (B)(6) DURING SEEG SURGERY A 2 HOUR DELAY OCCURRED DUE TO MULTIPLE FAILED REGISTRATION ATTEMPTS. THE VERIFICATION OF THE REGISTRATION SHOWED SIGNIFICANT DISCREPANCY BETWEEN ROBOT POSITION AND EXPECTED POSITION ON THE CT SCAN. FIELD SERVICE ENGINEER (FSE) ON SITE SUGGESTED THAT ANOTHER IMAGE BE TAKEN WITH THE O-ARM. THE SURGERY WAS DELAYED WHILE THE SURGEON WAITED ON THE O-ARM TO ARRIVE, WHICH TOOK APPROXIMATELY AN HOUR, DURING WHICH THE FSE ATTEMPTED TO TROUBLESHOOT. AFTER THE NEW IMAGE SET WAS TAKEN REGISTRATION WAS COMPLETED IMMEDIATELY. COMPARISON OF THE ORIGINAL CT TO THE O-ARM SCANS SHOWED THAT THE FIDUCIALS APPEARED TO HAVE SHIFTED." }, { "mdr_text_key": "312101812", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SEEG SURGERY, THE REGISTRATION OF THE PATIENT FAILED SEVERAL TIMES. A NEW IMAGE WAS TAKEN WITH THE O-ARM AND THEN THE REGISTRATION COULD BE PERFORMED. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION REGISTRATION FAILED MULTIPLE TIMES WITH A RMS VALUE OVER THE SPECIFICATION. THE BONE FIDUCIALS MARKERS OF THE FIRST IMAGE HAVE BEEN SHIFTED PROBABLY DUE TO AN UNDETECTED HEAD MOVEMENT DURING THE ACQUISITION OF THE CT SCAN." }, { "mdr_text_key": "312101813", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2018 AT (B)(6) WITH DR. (B)(6) DURING SEEG SURGERY A 2 HOUR DELAY OCCURRED DUE TO MULTIPLE FAILED REGISTRATION ATTEMPTS. THE VERIFICATION OF THE REGISTRATION SHOWED SIGNIFICANT DISCREPANCY BETWEEN ROBOT POSITION AND EXPECTED POSITION ON THE CT SCAN. FIELD SERVICE ENGINEER (FSE) ON SITE SUGGESTED THAT ANOTHER IMAGE BE TAKEN WITH THE O-ARM. THE SURGERY WAS DELAYED WHILE THE SURGEON WAITED ON THE O-ARM TO ARRIVE, WHICH TOOK APPROXIMATELY AN HOUR, DURING WHICH THE FSE ATTEMPTED TO TROUBLESHOOT. AFTER THE NEW IMAGE SET WAS TAKEN REGISTRATION WAS COMPLETED IMMEDIATELY. COMPARISON OF THE ORIGINAL CT TO THE O-ARM SCANS SHOWED THAT THE FIDUCIALS APPEARED TO HAVE SHIFTED." } ], "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": "03/20/2019" } ] }