{
  "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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            "No Code Available"
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20160831",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "mdr_text": [
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          "text_type_code": "Additional Manufacturer Narrative",
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          "text": "DEVICE RO 14 033 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSES. ACCURACY TESTING WAS CARRIED OUT ON THE DEVICE. ACCURACY OF THE DEVICE WAS CONFIRMED. AN ANALYSIS OF THE SOFTWARE LOG FILES WAS COMPLETED. THE INVESTIGATION FOUND THAT THE TRAJECTORY HAD BEEN MODIFIED BY THE SURGEON AFTER REGISTRATION. THE SURGICAL TECHNIQUE WAS FOUND TO BE A CONTRIBUTORY FACTOR TO PATIENT SKIN SHIFT. NO DEVICE DEFECT WAS DETECTED."
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        }
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
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      "suppl_dates_fda_received": ""
    }
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}