{
  "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_contact_zip_ext": "",
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      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "WI",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "1209 DEMING WAY",
      "manufacturer_contact_pcity": "60882429",
      "event_type": "Injury",
      "report_number": "3003873069-2022-00009",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20220609",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K170788",
      "date_of_event": "20220215",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "53717",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "6088242971",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "BIANK",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "608",
      "date_added": "20220613",
      "manufacturer_contact_f_name": "DANIEL",
      "device_date_of_manufacturer": "20061201",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1365407",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20220609",
          "brand_name": "CYBERKNIFE TREATMENT DELIVERY SYSTEM",
          "generic_name": "MEDICAL LINEAR ACCELERATOR",
          "manufacturer_d_name": "ACCURAY INCORPORATED",
          "manufacturer_d_address_1": "1209 DEMING WAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MADISON",
          "manufacturer_d_state": "WI",
          "manufacturer_d_zip_code": "53717",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "53717",
          "device_operator": "HEALTH PROFESSIONAL",
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          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "IYE",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Accelerator, Linear, Medical",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.5050",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "MD",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "05/25/2022",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250806",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6088",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20220609",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Disability"
          ],
          "patient_age": "63 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Inflammation",
            "Necrosis",
            "Brain Injury",
            "Inflammation",
            "Necrosis",
            "Brain Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220721",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "MADISON",
      "mdr_report_key": "14647602",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220525",
      "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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "294841255",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS EVENT IS CURRENTLY UNDER INVESTIGATION."
        },
        {
          "mdr_text_key": "294841256",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "A FEMALE PATIENT (CURRENTLY (B)(6)) RECEIVED CYBERKNIFE STEREOTACTIC RADIOSURGERY (SRS) IN 2018. ON (B)(6) 2022 DURING BRAIN SURGERY THE PATIENT WAS FOUND TO HAVE \"RADIATION-RELATED NECROSIS WITH CAVERNOMA-LIKE VASCULAR PROLIFERATION AND VASCULAR INFLAMMATION\"."
        },
        {
          "mdr_text_key": "331308053",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "CLINICAL AFFAIRS REVIEWED THE EVENT DETAILS. ACCURAY WAS MADE AWAY BY A CUSTOMER SITE OF A PATIENT THAT HAD CONFIRMED BRAIN NECROSIS RELATED TO RADIATION THERAPY TREATMENTS COMPLETED ON A CK SYSTEM. INTERVIEWS OF THE SITE ONCOLOGY NURSE AND MEDICAL PHYSICIST CONFIRMED INJURY IS A KNOWN SIDE EFFECT OF THE TREATMENT. PATIENT WAS MADE AWARE OF THE POTENTIAL SIDE EFFECTS IN THE SITE'S INFORMED CONSENT FORM. THE PATIENT'S PLAN WAS REVIEWED BY THE SITE AND THERE IS NO ALLEGATION THE SYSTEM MALFUNCTIONED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "53717",
      "manufacturer_contact_exchange": "608",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "07/21/2022"
    }
  ]
}