{
  "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": "",
      "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",
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      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20171221",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K163221",
      "date_of_event": "20171122",
      "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",
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20171122",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20171221",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "916460",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20171221",
          "brand_name": "MAZOR X",
          "generic_name": "MAZOR X",
          "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": "12 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"
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        }
      ],
      "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": "20171221",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "72 YR",
          "patient_sex": "",
          "patient_weight": "93",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20171221",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7137365",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20171122",
      "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": "95453305",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "EXEMPTION NUMBER E2017043."
        },
        {
          "mdr_text_key": "95453306",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DURING SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HEALTHCARE (US) ON (B)(6) 2017 MEDIAL TRAJECTORY AT L4 DUE TO SOFT TISSUE PRESSURE FROM BILATERAL RETRACTOR RESULTED IN PROLONGATION OF MORE THAN AN HOUR DUE TO THE NEED TO REVISE THE TRAJECTORY. INVESTIGATION CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND RELATED RISKS ARE WITHIN THE RISK ANALYSIS."
        }
      ],
      "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": ""
    }
  ]
}