{
  "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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      "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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          "serviced_by_3rd_party_flag": "U",
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          "brand_name": "EXCELSIUS GPS",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
      "health_professional": "",
      "summary_report_flag": "N",
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          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Unknown",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury"
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        }
      ],
      "distributor_city": "",
      "date_report": "20250129",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21264873",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250128",
      "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.",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "362434931",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "EGPS BATTERY DOES NOT HOLD ANYMORE. PLEASE SEND A FSR IMMEDIATELY TO REPLACE AND DO A SERVICE ON OUR MACHINE AT WESTCHESTER MEDICAL CENTER."
        },
        {
          "mdr_text_key": "362434932",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. AFTER THE PART REPLACEMENT WAS COMPLETE, THE SYSTEM WAS LEFT FULLY OPERATIONAL. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES NOT EXCEED THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "19403",
      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}