{
  "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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          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "udi_public": "00889095481297",
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      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
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      "summary_report_flag": "N",
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          "patient_sex": "Unknown",
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          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury"
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      "distributor_city": "",
      "date_report": "20250130",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21275458",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250129",
      "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": "362526585",
          "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. OUR INVESTIGATION WAS INCONCLUSIVE DUE TO CASE LOGS FROM THE PROCEDURE NOT BEING AVAILABLE DUE TO THE START-UP ERROR ENCOUNTERED. A FIELD SERVICE ENGINEER REPAIRED THE SYSTEM ON WORK ORDER. A SYSTEM FUNCTIONALITY TEST WAS PERFORMED, AND THE UNIT WAS LEFT FULLY OPERATIONAL. 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."
        },
        {
          "mdr_text_key": "362526586",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. SCREEN WENT TO A BLUE SCREEN WITH MESSAGE \"A START UP ERROR HAS OCCURRED\". TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED."
        }
      ],
      "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": ""
    }
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}