{
  "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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      "report_to_fda": "*",
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      "manufacturer_contact_area_code": "",
      "date_added": "20210420",
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          "manufacturer_d_state": "",
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          "device_evaluated_by_manufacturer": "",
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          "udi_public": "07290109180465",
          "openfda": {
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        "Adverse Event Without Identified Device or Use Problem"
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      "suppl_dates_mfr_received": "",
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      "manufacturer_contact_country": "",
      "date_changed": "20250729",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          ],
          "patient_age": "",
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          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
      ],
      "distributor_city": "",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11693738",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210325",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "246265057",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "246265058",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED BY THE PATIENT THAT THEIR LIFE WAS RUINED AND THEY EXPERIENCED A SIGNIFICANT LIFE CHANGING INJURY THROUGH USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY. THE PATIENT REPORTED HAD TWO SEPARATE PROCEDURE USING THE GUIDANCE SYSTEM."
        }
      ],
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      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}