{
  "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",
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      "pma_pmn_number": "K171651",
      "date_of_event": "20220914",
      "reprocessed_and_reused_flag": "N",
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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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      "date_added": "20221003",
      "manufacturer_contact_f_name": "DANIEL",
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          "implant_flag": "",
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          "device_sequence_number": "2611437",
          "implant_date_year": "2022",
          "date_removed_year": "2022",
          "serviced_by_3rd_party_flag": "U",
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          "brand_name": "EXCELSIUS",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120 V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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          "device_operator": "HEALTH PROFESSIONAL",
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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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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250803",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "date_received": "20221001",
          "sequence_number_treatment": [
            ""
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          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "Female",
          "patient_weight": "50 KG",
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          "patient_race": "",
          "patient_problems": [
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            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220929",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "15525540",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220915",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "19403",
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      "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": "300991794",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS REVEALED THAT THE MERGE OF ALL LEVELS CONTAINED A SHIFT IN BOTH THE AP AND LATERAL IMAGES. MERGE SHIFTS CAN CAUSE NAVIGATION INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE USER ACKNOWLEDGED THAT THEY PERFORMED AN ANATOMICAL LANDMARK CHECK ON THE OPERATIVE LEVELS TO ENSURE NAVIGATION INTEGRITY. ADDITIONALLY, INVESTIGATION OF THE CASE LOGS REVEALED THAT THE USER WORKED AWAY FROM THE REFERENCE BASE DURING SCREW PLACEMENT. THIS CAN RESULT IN CHANGES TO THE PATIENT ANATOMY RELATIVE TO THE REFERENCE BASE. BEFORE PROCEEDING WITH NAVIGATION, THE USER ACKNOWLEDGES THAT THEY WILL WORK TOWARDS THE REFERENCE BASE FROM THE DISTAL LEVEL TO LIMIT CHANGES IN REGISTRATION FOR MULTI-LEVEL SURGERY. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "300991795",
          "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. THIS EVENT OCCURED IN BELGIUM."
        }
      ],
      "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": ""
    }
  ]
}