{
  "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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      "date_changed": "20250806",
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          "patient_sex": "Unknown",
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            "Spinal Column Injury"
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        }
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      "distributor_city": "",
      "date_report": "20250124",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21233162",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240115",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
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      "mdr_text": [
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          "mdr_text_key": "362104889",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "MOTION CONTROL. COMMUNICATION FAILED ERROR. THIS KEEPS POPPING UP."
        },
        {
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          "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. THE USER DID NOT SUBMIT CASE LOGS FOR INVESTIGATION. ULTIMATELY, THE USER WAS UNABLE TO RESOLVE THE ISSUES WITHIN THE CASE AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THE SEVERITY IS OBSERVED DID NOT EXCEED THE ANTICIPATED 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 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",
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      "suppl_dates_fda_received": ""
    }
  ]
}