{
  "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": "3005075696-2018-00002",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20180109",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K163221",
      "date_of_event": "20171026",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "DISTRIBUTOR"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20171211",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20180109",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "20352",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180109",
          "brand_name": "MAZOR X",
          "generic_name": "STEROTACTIC INSTRUMENT",
          "manufacturer_d_name": "MAZOR ROBOTICS LTD.",
          "manufacturer_d_address_1": "5 SHACHAM ST.",
          "manufacturer_d_address_2": "NORTH INDUSTRIAL PARK",
          "manufacturer_d_city": "CAESAREA, ISRAEL",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "30889",
          "manufacturer_d_zip_code_ext": "00",
          "manufacturer_d_country": "IS",
          "manufacturer_d_postal_code": "3088900",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "TPL0059",
          "catalog_number": "TPL0059",
          "lot_number": "NA",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "HAW",
          "device_age_text": "13 MO",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "07290109180465",
          "udi_public": "07290109180465",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem",
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "CO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250821",
      "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": "20180109",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "78 YR",
          "patient_sex": "",
          "patient_weight": "73",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170109",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7177299",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20171211",
      "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": "96811351",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "EXEMPTION NUMBER E2017043."
        },
        {
          "mdr_text_key": "96811352",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "ON (B)(6) 2017, AT (B)(6) HOSPITAL (US), DR. (B)(6) PERFORMED AN L3-S1 FUSION SURGERY USING THE MAZOR X SYSTEM. INTRAOPERATIVELY THE SCREWS LOOKED ACCURATE, BUT POST-OPERATIVELY THE PATIENT SUFFERED FROM A DROP-FOOT. ON A POST-OP CT IT WAS NOTED THAT L3-L4 TRAJECTORIES WERE MEDIAL AND THESE WERE REVISED THE FOLLOWING DAY. THIS WAS REPORTED TO MAZOR ON (B)(4) 2017."
        }
      ],
      "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": ""
    }
  ]
}