{
  "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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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "date_added": "20170323",
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        {
          "device_event_key": "",
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          "serviced_by_3rd_party_flag": "",
          "date_received": "20170323",
          "brand_name": "ROSA SURGICAL DEVICE",
          "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE",
          "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, LANGUEDOC-ROUSSILLON",
          "manufacturer_d_state": "",
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          "device_availability": "Yes",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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        }
      ],
      "product_problems": [
        "Device Displays Incorrect Message",
        "Device Displays Incorrect Message"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250825",
      "health_professional": "",
      "summary_report_flag": "N",
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      "patient": [
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          "sequence_number_treatment": [
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          ],
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          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170317",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6427723",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20140508",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "70686350",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE RO 12 022 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT THE PC WAS DEGRADED DUE TO WEAR AND TEAR FROM USE. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4)."
        },
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT HAS BEEN REPORTED THAT DURING A SURGERY, THE PC WAS NON-FUNCTIONAL. NO PATIENT IMPACT WAS REPORTED. A SURGERY DELAY HAS BEEN REPORTED OF 40 MINUTES."
        }
      ],
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}