{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
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  },
  "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": "3004142400-2026-00137",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260630",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20260525",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "6109301800",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "PAUL",
      "source_type": [
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        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
      "reporter_country_code": "SN",
      "manufacturer_contact_area_code": "",
      "date_added": "20260630",
      "manufacturer_contact_f_name": "DANIEL",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "656051",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20260630",
          "brand_name": "EXCELSIUS GPS",
          "generic_name": "ROBOT, SURGICAL, NAVIGATION UNIT",
          "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-0459",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Human-Device Interface Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260922",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260630",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260630",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "25669139",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260604",
      "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": "406049117",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "406049118",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY, VERIFICATION OF ALL INSTRUMENTS AND END EFFECTORS WAS COMPLETED SUCCESSFULLY. WE WORKED ON MIS T12-L2 ROBOT-ASSISTED FRACTURE CASE WITH THE SURGEON BUT ENCOUNTERED AN ISSUE WITH ACCURACY. AFTER PLACING THREE SCREWS ON THE RIGHT SIDE, A SPIN REVEALED THAT THE L1 SCREW WAS OFFSIDE TOWARD THE MEDIAL CANAL, DESPITE THE PLAN BEING CORRECT. THE SURGEON WAS CONCERNED ABOUT THIS PLACEMENT ERROR, AS THE DRB AND SURVEILLANCE MARKERS WERE ALL CORRECTLY POSITIONED. HE DECIDED TO CHANGE THE PLAN AND COMPLETED THE CASE USING MEDTRONIC FREE HAND NAVIGATION. THE OPERATION WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS DOING WELL POST-OP."
        }
      ],
      "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": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}