{
  "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": {
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "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": "3009185973-2018-00174",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20180611",
      "manufacturer_address_2": "",
      "pma_pmn_number": "PK151359",
      "date_of_event": "20180606",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20180611",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
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          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "431384",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180611",
          "brand_name": "ROSA BRAIN",
          "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 BRAIN 3.0",
          "catalog_number": "N/A",
          "lot_number": "3.0.0.21",
          "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",
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            "device_class": "2"
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        }
      ],
      "product_problems": [
        "Computer Software Problem",
        "Computer Software Problem"
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      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "11/27/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250824",
      "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": "20180611",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Patient Involvement",
            "No Patient Involvement"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20181203",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7586967",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180606",
      "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": "111148476",
          "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."
        },
        {
          "mdr_text_key": "111148477",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WHEN TRYING TO LOAD EXAM, SCREEN POPPED UP SAYING \"IMPOSSIBLE TO LOAD EXAM\". THE FIELD SERVICE ENGINEER COULDN'T EXIT FROM EXAM MANAGER, SO HE HAD TO HARD REBOOT THE SYSTEM. ROBOT FUNCTIONED PROPERLY AFTER HARD REBOOT."
        },
        {
          "mdr_text_key": "130549856",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO LOAD AN EXAM DURING PRE-OPERATIVE PLANNING. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE CT SCAN COULD NOT BE LOADED BECAUSE IT CONTAINED TOO MANY SLICES. THE ROOT CAUSE OF THIS EVENT IS A USER ERROR WHO DID NOT FOLLOW THE IFU (ACQUISITION PROTOCOL)."
        },
        {
          "mdr_text_key": "130549857",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WHEN TRYING TO LOAD EXAM, SCREEN POPPED UP SAYING \"IMPOSSIBLE TO LOAD EXAM\". THE FIELD SERVICE ENGINEER COULDN'T EXIT FROM EXAM MANAGER, SO HE HAD TO HARD REBBOT THE SYSTEM. ROBOT FUNCTIONED PROPERLY AFTER HARD REBOOT. THEN, THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY DUE TO A MRI ISSUE. NO FAILURE OF THE DEVICE IS RELATED TO THE CONVERSION INTO TRADITIONAL SURGERY BUT THIS IS CONSIDERED AS A SERIOUS INJURY."
        }
      ],
      "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": "12/04/2018"
    }
  ]
}