{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "PA",
      "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": "3004142400-2024-00236",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20241028",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20231012",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "6109301800",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "PAUL",
      "source_type": [
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "610",
      "date_added": "20241028",
      "manufacturer_contact_f_name": "DANIEL",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1167736",
          "implant_date_year": "2023",
          "date_removed_year": "2023",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20241028",
          "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": "PA",
          "manufacturer_d_zip_code": "19403",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "19403",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "6143.1001",
          "catalog_number": "",
          "lot_number": "GPS-0309",
          "other_id_number": "",
          "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",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Connection Problem",
        "Connection Problem"
      ],
      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250822",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6109",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20241028",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Spinal Column Injury",
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20241025",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "20543599",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240926",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "19403",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "355176977",
          "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."
        },
        {
          "mdr_text_key": "355176978",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THIS WAS LIKELY A CASE OF THE PIB LOSING COMMUNICATION WITH THE GPS APPLICATION. THE ONLY KNOWN WORK-AROUND IS TO REBOOT THE SYSTEM, WHICH RESTORES FUNCTIONALITY. HOWEVER, PER THE INCIDENT DESCRIPTION, THE SYSTEM WAS NOT REBOOTED, BUT INSTEAD THE STABILIZERS WERE MANUALLY DISENGAGED AND THE SYSTEM WAS REMOVED FROM THE CASE. THE CASE WAS COMPLETED BY THE SURGEON PLACING THE SCREWS BY HAND. THE OBSERVED RISK LEVEL IS WITHIN THE ANTICIPATED RISK LEVEL. THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AN NO FURTHER INVESTIGATION IS REQUIRED."
        }
      ],
      "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": ""
    }
  ]
}