{
  "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_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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      "date_of_event": "20251117",
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          "serviced_by_3rd_party_flag": "U",
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          "generic_name": "ROBOT, SURGICAL, NAVIGATION UNIT",
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          "manufacturer_d_address_2": "",
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          "udi_public": "00889095481297",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260105",
      "health_professional": "Y",
      "summary_report_flag": "N",
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          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20251204",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "23719782",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20251119",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "386776251",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THERE WAS A RADIAL ERROR OF GREATER THAN 1.5MM AT MULTIPLE TRAJECTORIES. THE RIGHT OF ELECTRODE WAS REMOVED AND NO OTHER ELECTRODE WAS PLACED ALONG THIS PLANNED TRAJECTORY. NO FURTHER REVISION IS NEEDED."
        },
        {
          "mdr_text_key": "386776252",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ENGINEERING EVALUATION SHOWED THE \"RIGHT OF\" ELECTRODE WAS MISPLACED DURING THIS PROCEDURE. INVESTIGATION OF THE CASE REVEALED THE PATIENT FIXATION PINS SHIFTED BETWEEN THE INTRA-OPERATIVE AND POST-OPERATIVE SCANS. PIN SHIFTING OR PATIENT MOVEMENT CAN LEAD TO NAVIGATIONAL INACCURACIES AND MISPLACED IMPLANTS. ULTIMATELY, THE USER REMOVED THE ORIGINAL \"RIGHT OF\" ELECTRODE AND ACCURATELY PLACED A NEW ELECTRODE FOR THE OF TARGET. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THIS EVALUATION HAS BEEN COMPLETED VIA ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED."
        }
      ],
      "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",
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      "suppl_dates_fda_received": ""
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}