{
  "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",
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      "report_to_fda": "*",
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      "reporter_country_code": "US",
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          "manufacturer_d_address_2": "P.O. BOX 3104",
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          "manufacturer_d_zip_code_ext": "67",
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          "udi_di": "07290109180465",
          "udi_public": "07290109180465",
          "openfda": {
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      "suppl_dates_mfr_received": "",
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      "date_changed": "20250813",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          "patient_age": "",
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        }
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      "distributor_city": "",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "9711790",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180918",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "189208141",
          "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": "189208142",
          "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 THAT A 3DEFINE SCAN WAS COMPLETED AND REGISTRATION WAS ACHIEVED WITH AN O-ARM. LEFT AND RIGHT L2 WERE MEDIAL DUE TO SOFT TISSUE PRESSURE. THE RIGHT L2 TRAJECTORY PENETRATED THE DURA AND THE NERVE ROOT. THE CASE WAS ABORTED AFTER CONFIRMATION OF RIGHT L2 DEVIATION."
        }
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      "distributor_name": "",
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}