{
  "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,
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    }
  },
  "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": "3009185973-2017-00768",
      "type_of_report": [
        "Initial submission",
        "Followup",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20171109",
      "manufacturer_address_2": "",
      "pma_pmn_number": "PK151359",
      "date_of_event": "20171018",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH 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": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20171109",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "792457",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20171109",
          "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",
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          "catalog_number": "ROSAS00349",
          "lot_number": "3.0.0.20",
          "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": "NY",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "05/03/2018;03/29/2021",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "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": "20171109",
          "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": "20210329",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7012556",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20171018",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "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": "250753963",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS COMPLAINT IS BEING REMEDIATED UNDER AN ISSUE EVALUATION: COMPLAINTS ITEM NUMBERS REMEDIATION. THE ITEM NUMBER WAS UPDATED, THE CONCERNED MEDICAL DEVICE WAS THE LAPTOP COMPUTER AND NOT THE ROSA ROBOT. UNIQUE IDENTIFIER (UDI) #: UNKNOWN FOR THE LAPTOP COMPUTER."
        },
        {
          "mdr_text_key": "250753964",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING THE PLANNING OF THE SURGERY, SURGEON ATTEMPTED TO EXPORT PATIENT FOLDER FROM PLANNING STATION 5 TIMES FOLLOWING SHUTDOWNS, BEFORE IT WAS SUCCESSFUL."
        },
        {
          "mdr_text_key": "250773741",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE INVESTIGATION PERFORMED ON THE SURGERY DATA LOG FILE POINTED OUT THAT THE ISSUE WAS DUE TO A LACK OF MEMORY ON THE DESTINATION DISK. THE DEVICE WORKED AS INTENDED WITHIN SPECIFICATION."
        },
        {
          "mdr_text_key": "91414960",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE (B)(4) HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4). BECAUSE THE DELAY ON THE SURGERY WAS OF 30 MINUTES."
        },
        {
          "mdr_text_key": "91414961",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING THE PLANNING OF THE SURGERY, SURGEON ATTEMPTED TO EXPORT PATIENT FOLDER FROM PLANNING STATION 5 TIMES FOLLOWING SHUTDOWNS, BEFORE IT WAS SUCCESSFUL."
        }
      ],
      "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": "05/07/2018;04/06/2021"
    }
  ]
}