{
  "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_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250819",
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      "summary_report_flag": "N",
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          "sequence_number_treatment": [
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          "patient_sex": "Unknown",
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          "patient_problems": [
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        }
      ],
      "distributor_city": "",
      "date_report": "20230306",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "18844225",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "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.",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "336957645",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. THE REPORT WAS RECEIVED FROM FDA REQUESTING NO ACTION. REVIEW OF THE MAUDE DATABASE SHOWS THE REPORT TO LONGER BE LISTED. THE CONTACT INFORMATION FOR THE COMPLIANCE HOTLINE HAS BEEN ADDED TO THE COMPLAINT TRAINING FOR GLOBUS SALES FORCE AND AN EMAIL WAS SENT TO THE FIELD REGARDING WHEN AND HOW TO REPORT EVENTS TO CUSTOMER SERVICE OR COMPLAINTS."
        },
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          "mdr_text_key": "336957646",
          "text_type_code": "Description of Event or Problem",
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          "text": "IT WAS REPORTED ANONYMOUSLY TO FDA THROUGH A MEDWATCH 3500A FORM THAT A PATIENT EXPERIENCED SERIOUS ADVERSE EFFECTS FOLLOWING SCREW PLACEMENT WITH THE GLOBUS SPINE ROBOT. IT WAS REPORTED THAT THE SCREW(S) WERE NOT PLACED TO PLAN BY THE USER."
        }
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      "distributor_name": "",
      "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}