{
  "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.",
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      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
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      "summary_report_flag": "N",
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          "patient_race": "",
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        }
      ],
      "distributor_city": "",
      "date_report": "20250129",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "21264875",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250128",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
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      "mdr_text": [
        {
          "mdr_text_key": "362439557",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. HOWEVER, A FIELD SERVICE ENGINEER WAS SENT OUT TO REPLACE THE PDU AND BATTERY MODULE AND VERIFIED THE SYSTEM WAS OPERATING NORMALLY AND CHARGING CORRECTLY AFTERWARDS. AN FSE WAS SENT OUT AND REPLACE THE PDU AND BATTERY MODULE. THE SYSTEM WAS LEFT OPERATING NORMALLY AND CHARGING CORRECTLY. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. 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 AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "362439558",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "1-ROBOT WILL NOT HOLD A CHARGE OR STAY CHARGED, WHEN UNPLUGGED FROM THE WALL IT IMMEDIATELY DIES, POWERS DOWN."
        }
      ],
      "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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}