{
  "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": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "11/13/2024",
      "mfr_report_type": "Follow-Up",
      "manufacturer_contact_country": "US",
      "date_changed": "20250728",
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          "patient_race": "",
          "patient_problems": [
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            "Stroke/CVA",
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      "distributor_city": "",
      "date_report": "20241223",
      "initial_report_to_fda": "",
      "distributor_state": "",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
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      "number_devices_in_event": "",
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      "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": "",
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      "single_use_flag": "N",
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      "mdr_text": [
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED SHORTLY AFTER THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA."
        },
        {
          "mdr_text_key": "359067587",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE EVALUATION CONCLUSION WAS NOT YET AVAILABLE. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "360259023",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "NO SYSTEM MALFUNCTION WAS FOUND DURING THE REVIEW. AN INVESTIGATION OF THE LOGS SHOWED AN ACCURATE REGISTRATION WITH NO SHIFTS OR PATIENT MOVEMENT. ADDITIONALLY, THE USER REPORTED MER AND PATIENT STIMULATION RESPONSE TESTING WAS FAVORABLE, INDICATIVE OF ACCURATE PLACEMENT. ULTIMATELY, THIS CASE WAS ABORTED DUE TO THE PATIENT DISPLAYING LEFT LEFT-SIDED MUSCULAR WEAKNESS AND FACIAL PARALYSIS. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "360259024",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED SHORTLY AFTER THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA."
        }
      ],
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      "distributor_name": "",
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      "manufacturer_contact_postal_code": "19403",
      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "12/23/2024"
    }
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}