{
  "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": "",
      "manufacturer_contact_t_name": "MR.",
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          "udi_public": "0088909548129",
          "openfda": {
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250813",
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      "summary_report_flag": "N",
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          "patient_race": "",
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            "Spinal Column Injury"
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        }
      ],
      "distributor_city": "",
      "date_report": "20250509",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "22021777",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250416",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "370319832",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "NO CASE LOGS WERE PROVIDED, SO NO INVESTIGATION COULD BE PERFORMED. IT WAS REPORTED THAT THE IMPLANT WAS REPLACED SUCCESSFULLY. THE SEVERITY OBSERVED MATCHES THE ANTICIPATED COMPLAINT SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "370319833",
          "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."
        }
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      "suppl_dates_fda_received": ""
    }
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}