{
  "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_g1_city": "AUDUBON",
      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
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          "serviced_by_3rd_party_flag": "U",
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          "brand_name": "EXCELSIUS GPS",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "device_evaluated_by_manufacturer": "N",
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          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250822",
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      "summary_report_flag": "N",
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          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Unknown",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury"
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        }
      ],
      "distributor_city": "",
      "date_report": "20250124",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21232706",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250122",
      "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": "362160301",
          "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. ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS SHOWED THE USER HAD TO REHOME THE ARM MULTIPLE TIMES AND THE REHOMING PROCESS FAILED ON THE VERTICAL AXIS. WITHOUT PROPER HOMING, IT IS EXPECTED SYSTEM FUNCTIONALITY THAT THE ROBOT WOULD BE UNABLE TO SHOW REACHABILITY OR TRAJECTORIES. ULTIMATELY, THE USER WAS UNABLE TO RESOLVE THE ISSUES WITHIN THIS CASE AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. 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": "362160302",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "ROBOT NEVER CONFIRMED WE WERE IN TARGET OR WOULDN'T SEND TO ANY TRAJECTORIES."
        }
      ],
      "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": ""
    }
  ]
}