{
  "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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          "openfda": {
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      "date_changed": "20250822",
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      "summary_report_flag": "N",
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          "patient_race": "Black Or African American",
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        }
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      "distributor_city": "",
      "date_report": "20241007",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "20388895",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240906",
      "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": [
        {
          "mdr_text_key": "353599825",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. NO SYSTEM MALFUNCTION COULD BE VERIFIED DUE TO INSUFFICIENT INFORMATION. IT WAS REPORTED THAT PLACEMENT OF THE BIOPSY NEEDLE WAS ACCURATE AND THE SURGEON DID NOT ATTRIBUTE THIS ISSUE TO EGPS. 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. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "353599826",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, A BIOPSY SAMPLE WAS TAKEN AND CAUSED EXCESSIVE BLEEDING."
        }
      ],
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      "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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      "manufacturer_contact_postal_code": "19403",
      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}