{
  "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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      "report_to_fda": "",
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      "date_of_event": "20120611",
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      "manufacturer_contact_plocal": "",
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      "reporter_country_code": "JA",
      "manufacturer_contact_area_code": "",
      "date_added": "20120713",
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          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "date_received": "20120702",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "NA",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2653702",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120611",
      "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": "18053057",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "NA."
        },
        {
          "mdr_text_key": "17976266",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION."
        }
      ],
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      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}