{
  "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": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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      "pma_pmn_number": "PK151359",
      "date_of_event": "20161209",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH PROFESSIONAL",
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      "manufacturer_g1_postal_code": "",
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      "reporter_country_code": "FR",
      "manufacturer_contact_area_code": "",
      "date_added": "20180110",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180110",
          "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": "",
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          "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",
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          "device_availability": "Yes",
          "device_report_product_code": "HAW",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
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      "product_problems": [
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        "Computer Software Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
      "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": "20180110",
          "sequence_number_treatment": [
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          ],
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          "patient_age": "",
          "patient_sex": "",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180110",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7178388",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20170105",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "96844546",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "AN ANALYSIS OF THE DATA LOG FILES OF THE SUBJECT SURGERY WAS PERFORMED. THIS REVIEW INDICATED THAT THE REPORTED EVENT WAS CAUSED BY A SOFTWARE BUG PRESENT DUE TO A DESIGN FLAW."
        },
        {
          "mdr_text_key": "96844547",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING THE CONTACTLESS REGISTRATION PART OF THE SURGERY, A COMMUNICATION ERROR APPEARED. THE ROBOT ARM WAS IN EXCESSIVE EXTENSION WHEN IT WAS MOVING TO TEMPORAL SIDE. THIS ISSUED APPEARED BECAUSE TELESCOPIC ARM WAS TOO MUCH EXTENDED AND SO, PATIENT¿S HEAD WAS LOCKED TOO FAR FROM THE ROBOT ARM. THE DEVICE WAS RESTARTED AND THE TELESCOPIC ARM LENGTH WAS REDUCED IN ORDER TO ENSURE ACCESSIBILITY OF ALL SIDE OF THE PATIENT¿S HEAD. AFTER THIS MODIFICATION THERE WAS NO MORE REPORTED ISSUES."
        }
      ],
      "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": ""
    }
  ]
}