{
  "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": {
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "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": "3004142400-2026-00089",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260506",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20260407",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "6109301800",
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      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
      "reporter_country_code": "US",
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      "date_added": "20260506",
      "manufacturer_contact_f_name": "DANIEL",
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        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "626334",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20260506",
          "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",
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          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "19403",
          "device_operator": "HEALTH PROFESSIONAL",
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          "lot_number": "GPS-0609",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
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          "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"
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      "product_problems": [
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      "reporter_state_code": "GA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260709",
      "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": "20260506",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260506",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "25093727",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260408",
      "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": "400423639",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE DURING SURGERY. SCREWS WERE PLACED STARTING AT T10 ALL THE WAY TO THE PELVIS. E3D SPINS WERE PERFORMED FOR CONFIRMATION AND THE T10R HAD BREACHED MEDICAL 1-2 MM. THIS WAS THE SECOND SCREW PLACED BY THE ROBOT. THE SCREW WAS REPLACELY CORRECTLY."
        },
        {
          "mdr_text_key": "400423640",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. INVESTIGATION OF THE CASE LOGS INDICATED THAT THE MERGE THAT WAS ACCEPTED AT LEVELS T9-T12 WAS INACCURATE, WHICH RESULTED IN MISPLACED IMPLANTS. UPON CAREFULLY REVIEWING THE MERGE AT THE AFOREMENTIONED LEVELS, IT WAS REVEALED THAT THERE WAS A LATERAL SHIFT TO THE RIGHT AT ALL THESE LEVELS. THE USER IS ADVISED TO PERFORM A THOROUGH REVIEW OF THE MERGE BEFORE ACCEPTING IT. THE SEVERITY 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. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE."
        }
      ],
      "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": ""
    }
  ]
}