{
  "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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            "device_name": "Orthopedic Stereotaxic Instrument",
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      "date_changed": "20250819",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "18677613",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200805",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
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      "manufacturer_state": "",
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      "single_use_flag": "N",
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      "mdr_text": [
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          "mdr_text_key": "335072062",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A SCREW PLACED AT L5 WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE MISPLACED SCREW WAS REMOVED."
        },
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          "mdr_text_key": "335072063",
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          "text": "INVESTIGATION CONFIRMED THAT THERE WAS NO SYSTEM MALFUNCTION FOUND. THE ROOT CAUSE WAS USER TECHNIQUE. EXISTING MITIGATION'S SUFFICIENTLY REDUCE RISK TO HEALTH. THE ISSUE DOES NOT POSE A RISK TO HEALTH AND THERE ARE NO NEW SAFETY CONCERNS ASSOCIATE D WITH THIS ISSUE."
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      "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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    }
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}