{
  "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_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "manufacturer_link_flag": "Y",
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      "manufacturer_g1_city": "AUDUBON",
      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
      "event_type": "Injury",
      "report_number": "3004142400-2024-00542",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20250129",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20231222",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "6109301800",
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      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
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      "date_added": "20250129",
      "manufacturer_contact_f_name": "DANIEL",
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          "device_sequence_number": "1080214",
          "implant_date_year": "2023",
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          "serviced_by_3rd_party_flag": "U",
          "date_received": "20250129",
          "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",
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          "lot_number": "GPS-0407",
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          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "00889095481297",
          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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        "Human-Device Interface Problem"
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20250129",
          "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": "",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21263387",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250127",
      "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": "362390792",
          "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. THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF A NAVIGATION INTEGRITY FOR ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS WAS UNABLE TO DETERMINE A ROOT CAUSE DUE TO INSUFFICIENT INFORMATION. THE USER WAS UNABLE TO PROVIDE THE CASE LOGS FOR INVESTIGATION. HOWEVER, A GLOBUS MEDICAL REPRESENTATIVE AT THIS CASE NOTED THE PATIENT CONTINUED TO ATTEMPT TO MOVE HER HEAD THROUGHOUT THE PROCEDURE. PATIENT MOVEMENT CAN LEAD TO NAVIGATIONAL INACCURACIES AND MISPLACED LEADS. ULTIMATELY, THIS CASE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THESE REPEAT COMPLAINTS OCCURRED DURING APPROXIMATELY CRANIAL CASES, EQUATING TO AN OBSERVED OCCURRENCE OF THE SEVERITY IS OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. 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."
        },
        {
          "mdr_text_key": "362390793",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "WHEN ASSEMBLING THE A/O DRIVER AND ELECTRODE CLAMP GUIDE TUBE, IT WAS NOTED THAT THE SURGEON WAS ABLE TO SPIN THE E.C GUIDE TUBE. HOWEVER, THE E.C. GT APPEARED TO BE ASSEMBLED AS EXPECTED."
        }
      ],
      "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": ""
    }
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}