{
  "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",
    "results": {
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      "report_to_fda": "*",
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      "date_changed": "20250808",
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      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "12328339",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210729",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
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      "manufacturer_zip_code_ext": "",
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      "single_use_flag": "",
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      "mdr_text": [
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          "mdr_text_key": "266841434",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INVESTIGATION REVEALED NO SYSTEM MALFUNCTION WAS FOUND. THE SOFTWARE CORRECTLY DETECTED THE DYNAMIC REFERENCE BASE SHIFT AND DISPLAYED THE ON-SCREEN WARNING MESSAGE AND ALERTED THE USER OF A SURVEILLANCE SHIFT. NAVIGATION PROCEEDED WITHOUT COMPLETE RESOLUTION OF THE ERROR MESSAGE. EVALUATION OF THE CASE AND CASE LOGS FOUND THAT THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER ERROR. TO SUCCESSFULLY MOVE FORWARD WITH THE CASE FOLLOWING THE WARNING, THE USER WOULD NEED TO HAVE PERFORMED ANATOMICAL LANDMARK CHECKS OR COLLECT NEW IMAGING FOR THE PATIENT."
        },
        {
          "mdr_text_key": "266841435",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A REPRESENTATIVE FROM (B)(6) THAT DRILLING AT L4 TRAJECTORY CAUSED EXCESSIVE BLEEDING TO PATIENT THAT WAS FIXED INTRAOPERATIVELY."
        }
      ],
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}