{
  "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": {
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_address_2": "",
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      "manufacturer_contact_address_1": "",
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      "date_received": "20201125",
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      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20201125",
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          "date_received": "20201125",
          "brand_name": "EXCELSIUS GPS",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "AUDUBON",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "19403",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "19403",
          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "",
          "lot_number": "GPS-0103",
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          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        }
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20201125",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "63 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available"
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        }
      ],
      "distributor_city": "",
      "date_report": "20201116",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10900532",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201026",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "218194617",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INVESTIGATION CONFIRMED THAT THERE WAS NO SYSTEM MALFUNCTION FOUND. THE ROOT CAUSE WAS USER TECHNIQUE."
        },
        {
          "mdr_text_key": "218194618",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE PATIENT EXPERIENCED FOOT DROP POST-OPERATIVELY DUE TO SCREWS THAT WERE NOT PLACED TO PLAN. THE MISPLACED SCREWS WERE REMOVED AND REPLACED."
        }
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}