{
  "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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      "manufacturer_address_2": "",
      "pma_pmn_number": "K091999",
      "date_of_event": "20101207",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
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      "date_added": "20110113",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "generic_name": "CYBERKNIFE SYSTEM",
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          "manufacturer_d_city": "SUNNYVALE",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
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          "date_received": "20110106",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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            " O"
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          "patient_age": "NA",
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          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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      "manufacturer_contact_city": "",
      "mdr_report_key": "1957835",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20101207",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "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": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "20914273",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "COMPLICATIONS WERE DESCRIBED IN A CLINICAL PUBLICATION TITLED, 'STEREOTACTIC BODY RADIATION THERAPY FOR HEAD AND NECK TUMOR: DISEASE CONTROL AND MORBIDITY OUTCOMES.' ACCURAY CONTACTED THE PHYSICIAN RESPONSIBLE FOR THE TREATMENTS. IT WAS CONFIRMED THAT THE COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PTS DID NOT HAVE ANY OTHER TREATMENT ALTERNATIVE DUE TO THE NATURE AND EXTENT OF DISEASE; CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THESE PTS. THE PTS RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYSTEM IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. THE REPORTED TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION."
        },
        {
          "mdr_text_key": "21230233",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "NA"
        }
      ],
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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": ""
    }
  ]
}