{
  "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": "",
      "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": "3009185973-2013-00002",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20140211",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K101791",
      "date_of_event": "20131014",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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        "Health Professional"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "SP",
      "manufacturer_contact_area_code": "",
      "date_added": "20140311",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "88849",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20140211",
          "brand_name": "ROSA",
          "generic_name": "COMPUTER ASSISTED SURGICAL DEVICE (HAW)",
          "manufacturer_d_name": "MEDTECH",
          "manufacturer_d_address_1": "PARC DE BELLEGARDE",
          "manufacturer_d_address_2": "1 CHEMIN DE BORIE",
          "manufacturer_d_city": "CASTELANAU LE LEZ",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "3417",
          "manufacturer_d_zip_code_ext": "0",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "34170",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "ROSA",
          "catalog_number": "RO/ENG/V20/TC",
          "lot_number": "NA",
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          "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": [
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250817",
      "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": "20140211",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Life Threatening",
            " R"
          ],
          "patient_age": "64 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Intracranial Hemorrhage"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20131112",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3670221",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20131015",
      "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": "22365124",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A MEDTECH REPRESENTATIVE PERFORMED NON-CLINICAL TESTS WITH THE ROSA ROBOTIC SYSTEM AT THE HOSPITAL TO FURTHER INVESTIGATE CUSTOMER COMPLAINT. NO INACCURACY WAS FOUND AND SYSTEM WAS FOUND FULLY FUNCTIONAL. CUSTOMER HEAD FRAME COULD NOT HAVE BEEN TESTED YET. INCIDENT STILL UNDER INVESTIGATION."
        },
        {
          "mdr_text_key": "22140147",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2013, THE CUSTOMER USED THE ROSA DEVICE TO GUIDE THE IMPLANTATION OF 8 DEPTH ELECTRODES FOR A CRANIAL SEEG. DURING THE PROCEDURE, AN INTRACRANIAL HEMORRHAGE OCCURRED; IT WAS DETECTED LATER ON WITH THE POST-OPERATIVE CT-SCAN OF THE PT AND TREATED BY ADDITIONAL 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": ""
    }
  ]
}