{ "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": "3009185973-2021-00155", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210624", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210526", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "958423", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210624", "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": "3.1.4.1650", "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": [ "Failure to Power Up", "Failure to Power Up" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/04/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20210624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12056043", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210526", "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": "325947127", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE ROSA ONE DEVICE (B)(6) WOULD NOT POWER UP PRIOR TO A PROCEDURE. A COMPANY FIELD SERVICE ENGINEER INVESTIGATED THE SYSTEM AND DIAGNOSED A PROBLEM WITH THE ROBOT STAND COMPUTER. THIS INVESTIGATION INDICATED THAT THIS COMPUTER MOTHERBOARD WAS DAMAGED AND WILL NOT ALLOW PROPER BOOTING. ANOTHER COMPUTER WAS INSTALLED, WHICH RESOLVED THE REPORTED BOOTING ISSUE. FOLLOWING THIS EXCHANGE, THE FIELD SERVICE ENGINEER PERFORMED A COMPLETE PREVENTIVE MAINTENANCE AND FINAL SERVICE VERIFICATION TO ENSURE PROPER UTILIZATION OF THE ROSA ONE DEVICE (B)(6). BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE DUE TO A HARDWARE COMPONENT FAILURE (COMPUTER MOTHERBOARD)." }, { "mdr_text_key": "325947128", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WE ARE HAVING A PATTERN OF DIFFICULTIES WITH OUR ROSA MACHINE. THESE DIFFICULTIES ROUTINELY FOLLOW ANY SORT OF 'MAINTENANCE' PERFORMED BY THE REGIONAL TECHNICIANS. TODAY WE HAD TO CANCEL A SURGERY WITH THE PATIENT IN THE PRE-OPERATIVE AREA BECAUSE AFTER AN HOUR OF TROUBLESHOOTING, THE ROSA MACHINE STILL WOULD NOT CONNECT ITSELF TO THE MONITOR TO BE FUNCTIONAL. THE ROSA MACHINE WAS WORKING FINE PRIOR TO ITS LAST 'MAINTENANCE' BY THE REGIONAL TECHNICIAN. WE ARE NOW BEING TOLD THAT THE TECHNICIAN WILL NOT BE ABLE TO ATTEND TO THE REPAIR UNTIL NEXT WEEK CAUSING US TO POST-PONE THIS NEEDED SURGERY EVEN FURTHER." }, { "mdr_text_key": "258021150", "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. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "258021151", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WE ARE HAVING A PATTERN OF DIFFICULTIES WITH OUR ROSA MACHINE AT. THESE DIFFICULTIES ROUTINELY FOLLOW ANY SORT OF 'MAINTENANCE' PERFORMED BY THE REGIONAL TECHNICIANS. TODAY WE HAD TO CANCEL A SURGERY WITH THE PATIENT IN THE PRE-OPERATIVE AREA BECAUSE AFTER AN HOUR OF TROUBLESHOOTING, THE ROSA MACHINE STILL WOULD NOT CONNECT ITSELF TO THE MONITOR TO BE FUNCTIONAL. THE ROSA MACHINE WAS WORKING FINE PRIOR TO ITS LAST 'MAINTENANCE' BY THE REGIONAL TECHNICIAN. WE ARE NOW BEING TOLD THAT THE TECHNICIAN WILL NOT BE ABLE TO ATTEND TO THE REPAIR UNTIL NEXT WEEK CAUSING US TO POST-PONE THIS NEEDED SURGERY EVEN FURTHER." } ], "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": "08/05/2021" } ] }