{
  "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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    {
      "manufacturer_contact_zip_ext": "",
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      "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",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20221201",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
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      "reporter_occupation_code": "003",
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      "manufacturer_contact_f_name": "DANIEL",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20250123",
          "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": "",
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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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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250806",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20250123",
          "sequence_number_treatment": [
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          ],
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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"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250123",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21220739",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240114",
      "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": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "362039159",
          "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. A GLOBUS MEDICAL FIELD SERVICE ENGINEER VISITED THE CUSTOMER LOCATION AND REPLACED THE FUSES AND VOLTAGE SELECT MODULE AFTER CONFIRMING THE REPORTED FAILURE. 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": "362039160",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "WHEN ROBOT WAS PLUGGED IN, IT WOULD POWER UP BUT THEN START BEEPING AND BATTERY STATUS BAR WAS STUCK ON 2 BARS AND NOT CYCLING LIKE NORMAL. TURNED OFF ROBOT AND POWERED UP AGAIN AND BEEPING STOPPED BUT STILL WAS NOT WORKING PROPERLY. SHUT DOWN ONE LAST TIME AND POWERED BACK UP AND STARTED BEEPING AGAIN."
        }
      ],
      "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": ""
    }
  ]
}