{ "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": "*", "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": "3009185973-2017-00821", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20171213", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20171207", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20171213", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "894616", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171213", "brand_name": "ROSA SURGICAL DEVICE", "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": "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 SURGICAL DEVICE", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "N/A", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/15/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20171213", "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": "20180315", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7112069", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20171207", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification", "Inspection" ], "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": "250774067", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A TEST WAS PERFORMED TO RECREATE THE EVENT ON ANOTHER ROSA DEVICE WITH (B)(4) SOFTWARE VERSION WITH THE CT AS REFERENCE. A CRASH OCCURED AT THE SAME TIME THAN DESCRIBED IN THE COMPLAINT. THE ERROR IS AN INSUFFICIENT MEMORY TO ALLOW COMPUTING OF 3D RECONSTRUCTION OF THE CT. NEVERTHELESS 3D RECONSTRUCTION BUTTON WAS STILL AVAILABLE AND ALLOW TO DISPLAY THE INTERFACE FOR COMPUTING 3D RECONSTRUCTION. IT INDICATES THAT SOFTWARE WILL COMPUTE 3D RECONSTRUCTION BASED ON THE ¿BROWN-COLORED¿ PART OF THE IMAGE DISPLAYED ON AXIAL, SAGITTAL AND CORONAL VIEWS. IT IS A LOT OF INFORMATION AND MAY BE THE CAUSE OF THE INSUFFICIENT MEMORY. PLUS, ON THE IMAGE THE CT-SCAN HEAD CLAMP IS CLEARLY VISIBLE. IT IS AN EXTRA INFORMATION WHICH WILL BE USED FOR 3D RECONSTRUCTION AND MAY CONTRIBUTE TO FILL THE MEMORY DURING COMPUTATION. THIS INFORMATION IS NOT NECESSARY FOR ROSA USAGE. ACCORDING TO THE RESULTS OF THE TECHNICAL INVESTIGATION, THE EVENT WAS CAUSED BY A USER ERROR. TOO MANY INFORMATIONS WERE PRESENT ON THE LOADED IMAGES AND DID NOT ALLOW (B)(4)TO CREATE 3D RECONSTRUCTION BECAUSE OF AN INSUFFICIENT MEMORY." }, { "mdr_text_key": "94636792", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "94636793", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT MULTIPLE 3D RECONSTRUCTION PROBLEMS OCCURRED DURING THE PREPARATION OF THE SURGERY." } ], "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": "03/15/2018" } ] }