{
  "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": "I",
      "report_to_fda": "*",
      "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": "3005075696-2020-00097",
      "type_of_report": [
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      "date_received": "20200611",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K182077",
      "date_of_event": "20200529",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PHYSICIAN",
      "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": "20200611",
      "manufacturer_contact_f_name": "",
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      "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": "20200611",
          "brand_name": "MAZOR X STEALTH EDITION",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
          "manufacturer_d_name": "MAZOR ROBOTICS LTD",
          "manufacturer_d_address_1": "5 SHACHAM STREET",
          "manufacturer_d_address_2": "P.O. BOX 3104",
          "manufacturer_d_city": "CAESAREA HEFA,IL",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "30795",
          "manufacturer_d_zip_code_ext": "67",
          "manufacturer_d_country": "IL",
          "manufacturer_d_postal_code": "3079567",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "TPL0059",
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          "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"
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        }
      ],
      "product_problems": [
        "Use of Device Problem",
        "Use of Device Problem"
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      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "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": "20200611",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "79 YR",
          "patient_sex": "",
          "patient_weight": "108",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200611",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10144654",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200530",
      "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": "194843034",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE GUIDANCE SYSTEM. TESTING REVEALED NO ISSUES WITH THE GUIDANCE SYSTEM. THE GUIDANCE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "194843035",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY OF A SPINAL PROCEDURE TO TREAT DEGENERATIVE DISC WITH FIXATION. IT WAS REPORTED THAT A DAY AFTER THE SURGERY THEY DISCOVERED THAT THE L4 LEFT WAS MEDIAL TO PLAN. THE SUSPECTED CAUSE OF THE DEVIATION WAS SOFT TISSUE PRESSURE. A REVISION WAS DONE TO CORRECT THE SCREW. IT WAS UNKNOWN HOW MUCH THE SCREW WAS DEVIATED. THE MANUFACTURER REPRESENTATIVE HAD COMPLETED A 10 POINT ACCURACY CHECK TWICE AND THE SHOULDER CALIBRATION WAS IN SPECIFICATION AFTER THE PROCEDURE. THE GUIDANCE SYSTEM WAS USED IN TWO CASES WITHOUT ANY FURTHER ISSUE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED."
        }
      ],
      "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": ""
    }
  ]
}