{
  "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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      "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": "3004142400-2021-00009",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K171651",
      "date_of_event": "20201216",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "19403",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "6109301800",
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      "manufacturer_g1_postal_code": "19403",
      "manufacturer_g1_state": "PA",
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      "manufacturer_contact_area_code": "610",
      "date_added": "20240209",
      "manufacturer_contact_f_name": "DANIEL",
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        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1338859",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20240209",
          "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_zip_code": "19403",
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          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "19403",
          "device_operator": "HEALTH PROFESSIONAL",
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          "lot_number": "GPS-0237",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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            "device_class": "2"
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      ],
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        "Human-Device Interface Problem"
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      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250819",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6109",
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        {
          "patient_sequence_number": "1",
          "date_received": "20240209",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Spinal Column Injury",
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240209",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "18678380",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "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": "335030192",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING. THIS EVENT OCCURRED IN BELGIUM."
        },
        {
          "mdr_text_key": "335030215",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION CONFIRMED THAT THERE WAS NO SYSTEM MALFUNCTION FOUND. A SURVEILLANCE MARKER WAS REGISTERED, BUT ONLY AFTER THE PATIENT WAS REGISTERED. THIS COULD LEAD TO MOVEMENT OF THE PATIENT REFERENCE ARRAY DURING IMAGING OF THE PATIENT GOING UNNOTICED AND RESULTS IN TRACKING ERRORS. THERE WAS A SHIFT BETWEEN THE INTRA-OPERATIVE FLUOROSCOPIC IMAGES AND THE PRE-OPERATIVE CT SCAN. THIS SHIFT RESULTS IN POOR-QUALITY PATIENT REGISTRATION. THE USER WAS ALERTED OF HIGH SKIVING FORCE WHILE WORKING ON ALL LEVELS. HEAVY SKIVING COULD LEAD TO MOVEMENT OF THE ANATOMY. THESE FACTORS ALL CONTRIBUTED TO THE MISPLACEMENT OF THE SCREWS. THE CAUSE OF THE REPORTED ISSUE WAS DUE 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": ""
    }
  ]
}