{
  "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_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
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      "exemption_number": "",
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      "reporter_occupation_code": "003",
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          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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          "device_evaluated_by_manufacturer": "R",
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          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        "Human-Device Interface Problem"
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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": "20250810",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Female",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Spinal Column Injury"
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        }
      ],
      "distributor_city": "",
      "date_report": "20241008",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "20401297",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240910",
      "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": "353709459",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR INVESTIGATION WAS INCONCLUSIVE DUE TO CASE LOGS FROM THE PROCEDURE NOT BEING PROVIDED DESPITE MULTIPLE ATTEMPTS. THE DESCRIPTION PROVIDED STATES THAT THERE WERE MULTIPLE INSTANCES OF EXCESSIVE DEFLECTION WARNINGS WHICH LED TO NAVIGATION SHOWING THE SCREW PLACEMENT AS HIGH AND MEDIAL OF THE PEDICLE. EXCESSIVE DEFLECTION FORCE ON THE END EFFECTOR MAY CAUSE SKIVING DEPENDING ON THE TECHNIQUE OF THE USER. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "353709460",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND USING FLURO."
        }
      ],
      "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": ""
    }
  ]
}