{
  "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": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "1723170-2019-03080",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "date_received": "20190607",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K163221",
      "date_of_event": "20190510",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
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        "HEALTH"
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20190607",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
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          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20190607",
          "brand_name": "MAZOR X SYSTEM",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
          "manufacturer_d_name": "MEDTRONIC NAVIGATION, INC",
          "manufacturer_d_address_1": "826 COAL CREEK CIRCLE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "LOUISVILLE",
          "manufacturer_d_state": "CO",
          "manufacturer_d_zip_code": "80027",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "TPL0059",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
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          "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": [
        "Mechanical Jam",
        "Mechanical Jam"
      ],
      "reporter_state_code": "MO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/12/2019",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
      "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": "20190607",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Iatrogenic Source",
            "No Known Impact Or Consequence To Patient",
            "Iatrogenic Source",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20190710",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "8680462",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20190510",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "147383999",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "SYSTEM CHECK OUT WAS PERFORMED AND CONFIRMED THE EVENT. THE SHOULDER PISTON SENSOR WAS MOVED TO THE CORRECT LOCATION AND SECURED. THE SYSTEM PASSED ALL CHECKS AND TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "147384000",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT SHOULDER WILL NOT LOCK VIA PHYSICAL BUTTON OR SOFTWARE BUTTON. IT WAS NOTED THERE WAS NO PATIENT HARM BUT THE CASE WAS ABORTED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT."
        },
        {
          "mdr_text_key": "190741706",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO ADVERSE EVENT OR REPORTABLE PRODUCT PROBLEM. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO OUTCOME ATTRIBUTED TO AN ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SERIOUS INJURY, DEATH, OR REPORTABLE MALFUNCTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "190741707",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT WHEN THE SHOULDER WOULD NOT LOCK, THE MAZOR X PART WAS ABORTED. THE CASE STILL TOOK PLACE."
        }
      ],
      "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": "07/10/2019"
    }
  ]
}