{
  "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_t_name": "MR.",
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          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
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      "date_changed": "20250821",
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      "initial_report_to_fda": "",
      "distributor_state": "",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "20677437",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20241016",
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      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
      "adverse_event_flag": "Y",
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      "single_use_flag": "N",
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          "mdr_text_key": "356599573",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE CASE LOGS FROM THE PROCEDURE REVEALED THE CT SCAN UPLOAD FROM THE ROBOT FAILED, WHICH CAUSED A PARTIAL UPLOAD OF THE SCAN. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL."
        },
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          "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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}