{
  "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": "3009185973-2018-00119",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20180413",
      "manufacturer_address_2": "",
      "pma_pmn_number": "PK151359",
      "date_of_event": "20180403",
      "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": [
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        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20180413",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "272072",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180413",
          "brand_name": "ROSA BRAIN",
          "generic_name": "COMPUTER-ASSITED 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",
          "catalog_number": "N/A",
          "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",
        "Patient Data Problem",
        "Computer Software Problem",
        "Patient Data Problem"
      ],
      "reporter_state_code": "OH",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "11/02/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "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": "20180413",
          "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": "20181108",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7428096",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180403",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Notification",
        "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": "105370057",
          "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": "105370058",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT SURGEON WAS NOT ABLE TO LOAD IMAGES INTO THE PATIENT FOLDER THROUGH PACS. THE IMAGES WERE THEN BURNED TO A CD AND STILL COULD NOT BE READ. THE IMAGE WOULD NOT APPEAR ON THE IMAGE LOAD SCREEN AFTER THE CD HAD BEEN READ. THE IMAGE SERIES WAS TAKEN FROM THE CD AND MOVED INTO A DICOM FOLDER ON A USB DRIVE, AND TWO SLICES WITH DIFFERENT FILES SIZES FROM THE REST OF THE IMAGES WERE REMOVED. THE IMAGE WAS THEN ABLE TO LOAD AND BE VIEWED."
        },
        {
          "mdr_text_key": "310462678",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO LOAD IMAGES THROUGH PACS. A DHR AND A COMPLAINT HISTORY REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTOR TO THE EVENT. A FULL ANALYSIS OF DATA LOG AND AN IFU REVIEW INDICATES THAT THE MOST PROBABLE ROOT CAUSE OF THE ISSUE IS A NON RESPECT OF IFU RECOMMENDATIONS REGARDING THE SLICES SIZE. THEREFORE THE ROOT CAUSE IS A USER ERROR. CORRECTED DATA: DATE OF EVENT. DATE OF THIS REPORT. DESCRIBE EVENT OR PROBLEM. MANUFACTURER EMAIL ADDRESS. CONTACT OFFICE. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE. REMEDIAL ACTION."
        },
        {
          "mdr_text_key": "310462679",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SURGEON WAS NOT ABLE TO LOAD IMAGES INTO THE PATIENT FOLDER THROUGH PACS. THE IMAGES WERE THEN BURNED TO A CD AND STILL COULD NOT BE READ. THE IMAGE WOULD NOT APPEAR ON THE IMAGE LOAD SCREEN AFTER THE CD HAD BEEN READ. THE IMAGE SERIES WAS TAKEN FROM THE CD AND MOVED INTO A DICOM FOLDER ON A USB DRIVE, AND TWO SLICES WITH DIFFERENT FILES SIZES FROM THE REST OF THE IMAGES WERE REMOVED. THE IMAGE WAS THEN ABLE TO LOAD AND BE VIEWED."
        }
      ],
      "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": "11/09/2018"
    }
  ]
}