{
  "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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      "manufacturer_contact_zip_code": "",
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          "manufacturer_d_address_2": "",
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          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "date_changed": "20250729",
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          "date_received": "20201104",
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        }
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      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10788048",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201006",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
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      "single_use_flag": "",
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      "mdr_text": [
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          "mdr_text_key": "214652468",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INVESTIGATION CONFIRMED THAT THERE WAS NO SYSTEM MALFUNCTION FOUND. THE ROOT CAUSE WAS USER TECHNIQUE."
        },
        {
          "mdr_text_key": "214652469",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE AND REPLACE 4 SCREWS FROM T12 AND L2 THAT WERE NOT PLACED TO PLAN."
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}