{
  "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_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
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          "openfda": {
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      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
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          "patient_problems": [
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        }
      ],
      "distributor_city": "",
      "date_report": "20250128",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21263174",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250127",
      "manufacturer_name": "",
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      "remedial_action": [
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      "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": [
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          "mdr_text_key": "362387267",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE NAVIGATION WAS OFF DURING SURGERY AND SOME SCREWS WERE MISPLACED."
        },
        {
          "mdr_text_key": "362387268",
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          "patient_sequence_number": "0",
          "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. A ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. THE SOFTWARE CASE LOGS COULD NOT BE OBTAINED AFTER MULTIPLE GOOD FAITH ATTEMPTS. THE USER REPORTED THAT NAVIGATION WAS INACCURATE AND THEY MISSED SCREWS BECAUSE OF IT. THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. THE OBSERVED OVERALL RISK LEVEL IS LOW WHICH DOES NOT EXCEED THE OBSERVED ANTICIPATED RISK LEVEL. THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE."
        }
      ],
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      "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": ""
    }
  ]
}