{
  "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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      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "*",
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          "manufacturer_d_name": "MEDTECH SA",
          "manufacturer_d_address_1": "ZAC EUREKA",
          "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT",
          "manufacturer_d_city": "MONTPELLIER,",
          "manufacturer_d_state": "",
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          "manufacturer_d_country": "FR",
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          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250819",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "date_received": "20170407",
          "sequence_number_treatment": [
            ""
          ],
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
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          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170407",
      "initial_report_to_fda": "",
      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6471868",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20161108",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Inspection"
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "72102348",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DEVICE BR 16 017 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. TESTS CONFIRMED THAT THE DEVICE WAS OPERATING IN SPECIFICATION AND THE COLLISION AND SOFTWARE COMMUNICATION RESULTED FROM FAILURE TO FOLLOW THE CORRECT PROTOCOL. NO DEVICE DEFECT WAS DETECTED."
        },
        {
          "mdr_text_key": "72102349",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE WRIST OF THE ROBOT ARM HIT THE MAYFIELD SCREW, CAUSING A COLLISION THAT MADE THE SYSTEM SHUT DOWN. BECAUSE THERE WAS STILL PRESSURE BEING PUT ON THE ROBOT ARM BY THE MAYFIELD SCREW, THE SURGEON COULDN'T POWER THE ARM AGAIN TO MOVE IT IN COOPERATIVE MODE AND RESUME SURGERY. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}