{
  "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": "",
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      "event_location": "I",
      "report_to_fda": "N",
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      "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": "20180522",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K180307",
      "date_of_event": "20180412",
      "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": "",
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        "DISTRI"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20180412",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20180522",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
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          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180522",
          "brand_name": "MAZOR X",
          "generic_name": "STEREOTACTIC DEVICE",
          "manufacturer_d_name": "MAZOR ROBOTICS LTD.",
          "manufacturer_d_address_1": "5 SHACHAM ST.",
          "manufacturer_d_address_2": "NORTH INDUSTRIAL PARK",
          "manufacturer_d_city": "CAESAREA,",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "30889",
          "manufacturer_d_zip_code_ext": "00",
          "manufacturer_d_country": "IS",
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          "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": "1 YR",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "07290109180465",
          "udi_public": "07290109180465",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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            "device_class": "2"
          }
        }
      ],
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        "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": "20250820",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "date_received": "20180522",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "45 YR",
          "patient_sex": "",
          "patient_weight": "86",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180522",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7532552",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180423",
      "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": "108852578",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "EXEMPTION NUMBER E2017043. (B)(4)."
        },
        {
          "mdr_text_key": "108852579",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DURING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HOSPITAL CENTER (US), ON (B)(6) 2018, (REPORTED TO MAZOR ON APR. 23, 2018), INACCURATE SCREW PLACEMENT RESULTED IN A REVISION SURGERY."
        }
      ],
      "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": ""
    }
  ]
}