{
  "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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      "type_of_report": [
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      "date_of_event": "20160329",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH PROFESSIONAL",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20170323",
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        {
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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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          "manufacturer_d_zip_code_ext": "",
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          "manufacturer_d_postal_code": "34000",
          "device_operator": "HEALTH PROFESSIONAL",
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          "device_availability": "Yes",
          "device_report_product_code": "HAW",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
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          }
        }
      ],
      "product_problems": [
        "Computer Software Problem",
        "Computer Software Problem"
      ],
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20170323",
          "sequence_number_treatment": [
            ""
          ],
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          ],
          "patient_age": "",
          "patient_sex": "",
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          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170320",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6427841",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20160411",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "70686602",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE RO 14 042 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT A DESIGN DEFICIENCY CAUSED THE SOFTWARE FAILURE. 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, A SOFTWARE FAILURE HAS BEEN DETECTED. THE PATIENT DATA FILE WAS NOT ACCESSIBLE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR."
        }
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      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}