{ "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": "3009185973-2020-00166", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200630", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200722", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "774179", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200722", "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": "0", "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": [ "Image Display Error/Artifact", "Image Display Error/Artifact" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/22/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20200722", "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": "20201022", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10306788", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200630", "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": "199846853", "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. UDI# : (B)(4)." }, { "mdr_text_key": "199846854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING RNS PROCEDURE, CT WAS OBTAINED AFTER PATIENT WAS UNDER ANESTHESIA, NO INCISION. CT WAS UNABLE TO MERGE PROPERLY TO MP2RAGE IMAGE SERIES. BOTH AUTOMATIC AND SEMIAUTOMATIC FUSION WAS ATTEMPTED WITHOUT SUCCESS. SOFTWARE FROZEN WHILE ATTEMPTING TO ACCESS 'SEMI-AUTOMATIC' FUSION. ROSA SHUTDOWN AND RESTARTED TWICE. CT WAS DETERMINED TO HAVE ARTIFACT; SURGEON CHOSE TO GET ANOTHER CT SCAN TO SEE IF WOULD MERGE MORE SUCCESSFULLY. SECOND CT SCAN OBTAINED WHILE PATIENT UNDER ANESTHESIA AS WELL. CHALLENGE STILL WHILE ATTEMPTING TO MERGE TO MP2RAGE, AND T1 POST MRI. DELAY 1 HOUR, PATIENT UNDER ANESTHESIA, NO INCISION MADE. FOLLOWING SURGEON CONFIRMATION OF PROPER MERGE, SURGERY PROCEEDED." }, { "mdr_text_key": "321080037", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING RNS PROCEDURE, CT WAS OBTAINED AFTER PATIENT WAS UNDER ANESTHESIA, NO INCISION. CT WAS UNABLE TO MERGE PROPERLY TO MP2RAGE IMAGE SERIES. BOTH AUTOMATIC AND SEMIAUTOMATIC FUSION WAS ATTEMPTED WITHOUT SUCCESS. SOFTWARE FROZEN WHILE ATTEMPTING TO ACCESS 'SEMI-AUTOMATIC' FUSION. ROSA SHUTDOWN AND RESTARTED TWICE. CT WAS DETERMINED TO HAVE ARTIFACT; SURGEON CHOSE TO GET ANOTHER CT SCAN TO SEE IF WOULD MERGE MORE SUCCESSFULLY. SECOND CT SCAN OBTAINED WHILE PATIENT UNDER ANESTHESIA AS WELL. CHALLENGE STILL WHILE ATTEMPTING TO MERGE TO MP2RAGE, AND T1 POST MRI. DELAY 1 HOUR, PATIENT UNDER ANESTHESIA, NO INCISION MADE. FOLLOWING SURGEON CONFIRMATION OF PROPER MERGE, SURGERY PROCEEDED." }, { "mdr_text_key": "321080038", "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 CONCLUDED THAT THE AUTOMATIC MERGE OF THE FIRST CT PRE-OPERATIVE WITH BOTH REFERENCE MRIS FAILED DUE TO THE POOR QUALITY OF ALL EXAMS. IT REQUIRED ADJUSTMENTS WHICH WERE FINALLY PERFORMED BY THE USER. THE DEVICE BEHAVED AS EXPECTED. THE SECOND CT WAS NOT PROVIDED FOR THE INVESTIGATION BUT THE QUALITY OF REFERENCE EXAMS IS ALSO PROBABLY THE CAUSE FOR THE AUTOMATIC MERGE FAILURES. THE CRASH OF THE APPLICATION DURING THE HALF-AUTOMATIC MERGE IS CONFIRMED BUT THE CAUSE CANNOT BE DETERMINED." } ], "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": "10/28/2020" } ] }