{
  "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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          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
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            "device_name": "Orthopedic Stereotaxic Instrument",
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      "manufacturer_contact_country": "US",
      "date_changed": "20250819",
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      "summary_report_flag": "N",
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          "patient_race": "White",
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      "distributor_city": "",
      "date_report": "20240228",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "18810005",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20231107",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "336584180",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. REVIEW OF THE PATIENT REGISTRATION FOR L2 AND L3 REVEALED THAT THERE ARE PREOPERATIVE MERGE SHIFTS PRESENT. PREOPERATIVE MERGE SHIFTS CAN CAUSE NAVIGATIONAL INTEGRITY ISSUES AND CAN LEAD THE MISPLACEMENT OF SCREWS. THE USER MUST VERIFY THE MERGE BEFORE PROCEEDING. ADDITIONALLY, THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK TO ENSURE NAVIGATIONAL INTEGRITY BEFORE PROCEEDING WITH NAVIGATION. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "336584183",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM."
        }
      ],
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      "manufacturer_contact_postal_code": "19403",
      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}