{
  "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",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "AUDUBON",
      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
      "event_type": "Injury",
      "report_number": "3004142400-2024-00202",
      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "N",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20240507",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "PHYSICIAN",
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      "manufacturer_g1_postal_code": "19403",
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          "serviced_by_3rd_party_flag": "U",
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          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "manufacturer_d_address_2": "",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        }
      ],
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      "reporter_state_code": "IN",
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      "suppl_dates_mfr_received": "02/20/2026",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260401",
      "health_professional": "Y",
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          "sequence_number_treatment": [
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          ],
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          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Spinal Column Injury",
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260313",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "20216338",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240819",
      "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": "351832341",
          "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 AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY."
        },
        {
          "mdr_text_key": "351832342",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "NO INFORMATION WAS AVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        }
      ],
      "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": "03/13/2026"
    }
  ]
}