{
  "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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  },
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "manufacturer_link_flag": "Y",
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      "manufacturer_g1_city": "AUDUBON",
      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
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      "report_number": "3004142400-2024-00252",
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      "date_of_event": "20241007",
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          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
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          "device_report_product_code": "OLO",
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          "device_evaluated_by_manufacturer": "R",
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          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
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      "reporter_state_code": "CT",
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      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260401",
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          "sequence_number_treatment": [
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          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury",
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      ],
      "distributor_city": "",
      "date_report": "20260313",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
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      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20241009",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "19403",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "N",
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      "mdr_text": [
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          "mdr_text_key": "356088133",
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        },
        {
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
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      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "03/13/2026"
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  ]
}