{
  "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": "3009185973-2021-00045",
      "type_of_report": [
        "Initial submission",
        "Followup",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20210218",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K200511",
      "date_of_event": "20210120",
      "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": "FR",
      "manufacturer_contact_area_code": "",
      "date_added": "20210218",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "242421",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20210218",
          "brand_name": "ROSA ONE SYSTEM - EU PLUG E",
          "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 3.1",
          "catalog_number": "ROSAS00201",
          "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": [
        "Computer Software Problem",
        "Computer Software Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "09/17/2021;09/27/2021",
      "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": "20210218",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210927",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11344097",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210120",
      "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": "232587033",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "UDI# : (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": "232587034",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OPERATING ROOM AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED."
        },
        {
          "mdr_text_key": "326174879",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE USER DELETED THE PATIENT FOLDER FROM THE PLANNING SESSION USING THE SOFTWARE AND THEN, ATTEMPTED TO COPY IT ON A USB FROM MAINTENANCE SESSION DIRECTLY. THE EXTENSION OF THE PATIENT FOLDER FILE WAS CHANGED AFTER DELETION WHICH PREVENTED THE PATIENT FOLDER TO BE OPENED ON PLANNING STATION AGAIN. THE WAY TO EXPORT THE FOLDER WAS NOT THE ONE RECOMMENDED BY THE IFU. THE DEVICE BEHAVED AS EXPECTED."
        },
        {
          "mdr_text_key": "326174880",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OR AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED."
        },
        {
          "mdr_text_key": "326366146",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "UDI# : (B)(4)."
        },
        {
          "mdr_text_key": "326366147",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OR AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED."
        }
      ],
      "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": "09/24/2021;09/27/2021"
    }
  ]
}