{
  "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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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "*",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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        "Followup"
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      "date_of_event": "20180703",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
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      "manufacturer_contact_plocal": "",
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        "HEALTH"
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
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      "date_added": "20180803",
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      "device": [
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          "serviced_by_3rd_party_flag": "",
          "date_received": "20180803",
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          "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": "",
          "manufacturer_d_zip_code": "34000",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "34000",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "ROSA BRAIN",
          "catalog_number": "N/A",
          "lot_number": "3.0.0.21",
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          "device_availability": "Yes",
          "device_report_product_code": "HAW",
          "device_age_text": "DA",
          "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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        }
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      "product_problems": [
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        "Computer Software Problem"
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      "reporter_state_code": "MI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "09/19/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20180803",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180924",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7746822",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180703",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "115919167",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)."
        },
        {
          "mdr_text_key": "115919168",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING REGISTRATION A SLOWDOWN ERROR OCCURRED. FIELD SERVICE ENGINEER PRESSED THE \"OK\" BUTTON TO CONTINUE. THEY WERE ABLE TO CONTINUE, BUT THE ERROR WINDOW STAYED PRESENT IN THE BACKGROUND AND THE ERROR CHIME PERSISTED. THEY PROGRESSED FURTHER IN THE REGISTRATION PROCESS HOPING TO REACH A POINT WHERE PROGRESS COULD BE SAVED. HOWEVER, \"ROSANNA\" CRASHED DURING THE ACCESSIBILITY CHECK. THIS CRASH CAUSED A LOSS OF SOME DATA BECAUSE IT WAS NOT SAVED BEFORE STARTING REGISTRATION. THE SURGEON HAD MADE MODIFICATIONS TO SOME TRAJECTORIES THAT WAS LOST. THE FIDUCIAL MARKERS HAD TO BE RE-DEFINED. THE REGISTRATION WAS NOT SAVED AND HAD TO BE REPEATED. OVERALL, THIS SOFTWARE CRASH DELAYED THE CASE BY ABOUT AN HOUR."
        },
        {
          "mdr_text_key": "310461272",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT TWO SHUTDOWNS OCCURRED. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. TECHNICAL INVESTIGATION CONFIRMED THAT TWO SHUTDOWNS OCCURRED. ONE OCCURRED DUE TO A PERFORMANCE SLOWDOWN OF THE COMPUTER AND ONE DUE TO A KNOWN DESIGN DEFECT."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "09/25/2018"
    }
  ]
}