{
  "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": "NO INFORMATION",
      "report_to_fda": "I",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      ],
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      "pma_pmn_number": "",
      "date_of_event": "20191205",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      ],
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20191213",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1257802",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20191212",
          "brand_name": "MAZOR X",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
          "manufacturer_d_name": "MAZOR ROBOTICS LTD / MEDTRONIC",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "MAZOR X",
          "catalog_number": "X",
          "lot_number": "TPL0059",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Device Dislodged or Dislocated"
      ],
      "reporter_state_code": "CO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "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": "20191212",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "69 YR",
          "patient_sex": "",
          "patient_weight": "102",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Failure of Implant",
            "Failure of Implant"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20191210",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "9467182",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "170940813",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WHILE USING THE MAZOR NAVIGATION / ROBOTIC SYSTEM LEFT SIDE SCREWS OF A SPINAL FUSION WERE IN PLACE. THE RIGHT SIDED SCREWS WERE MEDIAL DISPLACED AND REQUIRED RE POSITIONING. FDA SAFETY REPORT ID# (B)(4)."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}