{ "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": "3009185973-2019-00190", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190603", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190507", "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": "20190603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "457841", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190603", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/20/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20190603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20190715", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8663334", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190507", "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": "146818188", "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": "146818189", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY, WHEN TRYING TO MERGE AN O-ARM SPIN FOR REGISTRATION PURPOSES, THE RESULTING AUTOMATIC MERGE WAS VERY POOR. SEVERAL ATTEMPTS TO MERGE WITH BOTH THE PRE-OP CT AND MRI WERE BAD. SEMI-AUTOMATIC MERGE DID NOT WORK WELL EITHER. PATIENT WENT DOWN TO CT TO GET A NEW SCAN, AND THE RESULTANT STUDY HAD THE SAME MERGE ISSUES. SURGEON ENDED UP PERFORMING CONTACTLESS REGISTRATION." }, { "mdr_text_key": "312104798", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, WHEN TRYING TO MERGE AN O-ARM SPIN FOR REGISTRATION PURPOSES, THE RESULTING AUTOMATIC MERGE WAS VERY POOR. SEVERAL ATTEMPTS TO MERGE WITH BOTH THE PRE-OP CT AND MRI WERE BAD. SEMI-AUTOMATIC MERGE DID NOT WORK WELL EITHER. PATIENT WENT DOWN TO CT TO GET A NEW SCAN, AND THE RESULTANT STUDY HAD THE SAME MERGE ISSUES. SURGEON ENDED UP PERFORMING CONTACTLESS REGISTRATION." }, { "mdr_text_key": "312104799", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE USER INDICATED THAT THE RESULT FROM THE AUTOMATIC MERGE AND SEMI-AUTOMATIC MERGE WAS NOT SATISFYING. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION INDICATED THAT THE MERGE ATTEMPT WITH THE FIRST CT COULD HAVE BEEN ADJUSTED MANUALLY BY THE USER TO OBTAIN A CORRECT RESULT. THE USER MANUAL PROVIDES NECESSARY INFORMATION TO ADJUST EXAMS TO EACH OTHER AND GET A SATISFYING RESULT. THE TECHNICAL INVESTIGATION INDICATED THAT THE MERGE ATTEMPT WITH THE SECOND CT COULD NOT PROVIDE A SATISFYING RESULT BECAUSE THE EXAM WAS ACQUIRED WITH A GANTRY TILT OF 4 DEGREES. EXAMS ACQUIRED WITH A GANTRY TILT ARE NOT CORRECTLY MANAGED BY THE ROSA BRAIN DEVICE, HOWEVER, THIS IS NOT SPECIFIED IN THE ACQUISITION PROTOCOL IFU. THIS MISSING INFORMATION IS RECORDED AS A DESIGN DEFECT." } ], "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": "07/15/2019" } ] }