{ "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": "3009185973-2020-00114", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200401", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200312", "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": "20200401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "374405", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200401", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "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": "04/29/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20200401", "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": "20200506", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9911029", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200312", "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": "318035939", "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. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND SHOWED THAT THE AUTOMATIC MERGE OF THE CT ON MRI FAILED BECAUSE THE CT CONTAINS MORE INFORMATION THAN THE MRI REFERENCE EXAM WHICH IS A CONDITION OF THE AUTOMATIC MERGE FAILURE AND A NORMAL BEHAVIOR OF THE DEVICE. THE MERGE COULD HAVE BEEN ADJUSTED MANUALLY BUT THE USER WAS NOT CONFIDENT WITH THAT AND PREFERRED TO REWORK HIS PLANNING ENTIRELY. THEREFORE, A SIGNIFICANT DELAY WAS OBSERVED. 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" }, { "mdr_text_key": "318035940", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AROUND 9:00 EST, THE BONE FIDUCIAL CT SCAN WAS ATTEMPTED TO BE MERGED TO THE MRI SCAN ALREADY LOADED INTO THE PLAN WITH TRAJECTORIES PLACED. THE CT SCAN WAS TAKEN BY THE AIRO SCANNER, AND THE PATIENT WAS PRONE AND CONNECTED TO ROSA WITH A RADIOLUCENT MAYFIELD HEAD HOLDER. WHEN TRYING TO MERGE THE CT SCAN TO THE MRI SCAN, THE MERGE FAILED, AND THE SURGEON ATTEMPTED TO MANUALLY MERGE THE IMAGING, BUT WAS UNSUCCESSFUL. THE SEMI-AUTOMATIC MERGE FUNCTION WAS ATTEMPTED AS WELL, BUT THAT MADE THE MERGE EVEN WORSE. THE SURGEON COMPLAINED THAT MANUALLY MERGING THE SCAN WOULD TAKE TOO LONG AND THE ACCURACY WOULDN'T BE TRUST-ABLE FOR SURGERY. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO MERGE THE MRI TO THE CT SCAN (OPPOSITELY MERGING THE SCANS), AND THIS APPEARED TO HAVE WORKED CORRECTLY. THE SURGEON WAS OKAY WITH THE MERGE, BUT THAT MEANT THE TRAJECTORIES THEY PLANNED WERE LOST, SO THEY WERE UPSET THEY LOST EVERYTHING THEY PLANNED, AND WASTED THEIR TIME. THE SURGEON RE-PLANNED THE TRAJECTORIES BASED ON THE NEW MERGE, BUT IT TOOK ABOUT AN HOUR TO FINALIZE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. THE DELAY WAS OVER AN HOUR DUE TO MERGING ISSUES AND RE-PLANNING TRAJECTORIES." }, { "mdr_text_key": "196489239", "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": "196489240", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AROUND 9:00 EST, THE BONE FIDUCIAL CT SCAN WAS ATTEMPTED TO BE MERGED TO THE MRI SCAN ALREADY LOADED INTO THE PLAN WITH TRAJECTORIES PLACED. THE CT SCAN WAS TAKEN BY THE AIRO SCANNER, AND THE PATIENT WAS PRONE AND CONNECTED TO ROSA WITH A RADIOLUCENT MAYFIELD HEAD HOLDER. WHEN TRYING TO MERGE THE CT SCAN TO THE MRI SCAN, THE MERGE FAILED, AND THE SURGEON ATTEMPTED TO MANUALLY MERGE THE IMAGING, BUT WAS UNSUCCESSFUL. THE SEMI-AUTOMATIC MERGE FUNCTION WAS ATTEMPTED AS WELL, BUT THAT MADE THE MERGE EVEN WORSE. THE SURGEON COMPLAINED THAT MANUALLY MERGING THE SCAN WOULD TAKE TOO LONG AND THE ACCURACY WOULDN'T BE TRUST-ABLE FOR SURGERY. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO MERGE THE MRI TO THE CT SCAN (OPPOSITELY MERGING THE SCANS), AND THIS APPEARED TO HAVE WORKED CORRECTLY. THE SURGEON WAS OKAY WITH THE MERGE, BUT THAT MEANT THE TRAJECTORIES THEY PLANNED WERE LOST, SO THEY WERE UPSET THEY LOST EVERYTHING THEY PLANNED, AND WASTED THEIR TIME. THE SURGEON RE-PLANNED THE TRAJECTORIES BASED ON THE NEW MERGE, BUT IT TOOK ABOUT AN HOUR TO FINALIZE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. THE DELAY WAS OVER AN HOUR DUE TO MERGING ISSUES AND RE-PLANNING TRAJECTORIES." } ], "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": "05/06/2020" } ] }