{
  "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_t_name": "MR.",
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      "manufacturer_g1_city": "AUDUBON",
      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "manufacturer_contact_pcity": "61093018",
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      "report_number": "3004142400-2022-00041",
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      "pma_pmn_number": "K171651",
      "date_of_event": "20220220",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20220323",
          "brand_name": "EXCELSIUS ROBOTICS SYSTEM",
          "generic_name": "SYSTEM, EXCELSIUS GPS, 120V",
          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "sequence_number_treatment": [
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      "date_report": "20220304",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "13862148",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220221",
      "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": "",
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      "single_use_flag": "N",
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      "mdr_text": [
        {
          "mdr_text_key": "287696327",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE ENTIRE VERTEBRAL BODY OF L3 IS NOT CAPTURED WITHIN THE PREOPERATIVE CT SCAN. THE INFERIOR END PLATE IS OMITTED FROM THE SCAN. THIS CAN CONTRIBUTE TO DIFFICULTIES IN OBTAINING A SUCCESSFUL MERGE. USERS ARE TRAINED ON THE APPROPRIATE IMAGING ACQUISITION PROTOCOL DURING THE EXCELSIUSGPS TRAINING PATHWAY. ADDITIONALLY, FOR LEVELS WHERE SCREWS WERE MISPLACED, THE FLUOROSCOPIC AP IMAGES CONTAINED TRACKING ERRORS. A TRACKING ERROR CAN BE CAUSED IF THE POSITION OF THE C-ARM CHANGED BETWEEN WHEN THE ORIGINAL X-RAY WAS EMITTED AND WHEN THE IMAGE IS UPLOADED TO THE SYSTEM. FURTHERMORE, THERE IS A SHIFT PRESENT IN THE AP IMAGE OF THE PREOPERATIVE MERGE. TRACKING ERRORS AND MERGE SHIFTS CAN CAUSE NAVIGATION INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE USER MUST VERIFY THE MERGE BEFORE PROCEEDING TO NAVIGATION. AFTER VERIFYING THE MERGE, THE SOFTWARE PROMPTS THE USER TO PERFORM AN ANATOMICAL LANDMARK CHECK BEFORE PROCEEDING WITH NAVIGATION. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "287696328",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE AND REPLACE MISPLACED SCREWS."
        }
      ],
      "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": ""
    }
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}