{
  "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.",
      "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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      "date_of_event": "20220715",
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      "exemption_number": "",
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      "reporter_occupation_code": "003",
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      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
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      "manufacturer_contact_area_code": "610",
      "date_added": "20220808",
      "manufacturer_contact_f_name": "DANIEL",
      "previous_use_code": "R",
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        {
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          "implant_flag": "",
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          "device_sequence_number": "2278965",
          "implant_date_year": "2022",
          "date_removed_year": "2022",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20220808",
          "brand_name": "EXCELSIUS",
          "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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          "manufacturer_d_country": "US",
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          "device_report_product_code": "OLO",
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          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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      "product_problems": [
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      "reporter_state_code": "PA",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250811",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6109",
      "patient": [
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          "date_received": "20220808",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          "patient_age": "66 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available",
            "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220802",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "15182134",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220715",
      "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": "297412115",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM."
        },
        {
          "mdr_text_key": "297412116",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THERE WAS NO SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS AND A COMPARISON OF THE INTRA-OPERATIVE SCAN TO POST-OPERATIVE SPIN REVEALED THAT THERE WAS MOVEMENT OF THE INTRA-OPERATIVE CT REGISTRATION FIXTURE (ICT). THIS MOVEMENT OCCURRED BETWEEN WHEN THE SURGICAL SNAPSHOT IS CAPTURED AND WHEN THE SCAN IS UPLOADED TO THE SYSTEM. A SHIFT OF THE ICT CAN LEAD TO A LOSS OF NAVIGATION INTEGRITY AND THE MISPLACEMENT OF SCREWS. THE USER ACKNOWLEDGES THAT THEY WILL PERFORM AN ANATOMICAL LANDMARK CHECK ON THE OPERATIVE LEVELS TO ENSURE NAVIGATION INTEGRITY AFTER THE REGISTRATION AND BEFORE NAVIGATION. THE CAUSE OF THE REPORTED ISSUE WAS 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": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}