{
  "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",
      "event_type": "Injury",
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      "date_of_event": "20221128",
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          "serviced_by_3rd_party_flag": "U",
          "date_received": "20250123",
          "brand_name": "EXCELSIUS GPS",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        "Human-Device Interface Problem"
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250806",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Unknown",
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          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250123",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21220307",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240114",
      "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": "362033160",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "CALLED SERVICE WHEN THE ROBOT BATTERY WOULD NOT CHARGE. WAS TOLD THE ROBOT WOULD STILL GET POWER WHILE PLUGGED IN, IT WAS WORKING FOR AROUND AN HOUR THEN POWERED DOWN BEFORE REGISTRATION AND WOULD NOT START. SURGERY ABORTED."
        },
        {
          "mdr_text_key": "362033161",
          "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. A GLOBUS MEDICAL FIELD SERVICE ENGINEER VISITED THE CUSTOMER LOCATION AND REPLACED THE FUSES AFTER CONFIRMING THE REPORTED FAILURE. THE OBSERVED OVERALL RISK LEVEL IS LOW WHICH MATCHES 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."
        }
      ],
      "number_patients_in_event": "",
      "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": ""
    }
  ]
}