{
  "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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      "event_location": "I",
      "report_to_fda": "*",
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      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3009185973-2017-00536",
      "type_of_report": [
        "Initial submission"
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      "product_problem_flag": "N",
      "date_received": "20170406",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K151359",
      "date_of_event": "20160606",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "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": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20170406",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "246034",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20170406",
          "brand_name": "ROSA BRAIN",
          "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,",
          "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 3.0",
          "catalog_number": "",
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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",
            "regulation_number": "882.4560",
            "device_class": "2"
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        }
      ],
      "product_problems": [
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        "Calibration Problem"
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      "reporter_state_code": "OH",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250814",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20170406",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Hematoma"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170406",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6463957",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20160606",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Repair"
      ],
      "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": "71882831",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DEVICE BR 16 006 WAS INSPECTED FOR INVESTIGATION PURPOSES. THE INVESTIGATION IDENTIFIED THAT A SOFTWARE WARNING MESSAGE ALERTED THE SURGEON THAT THE REGISTRATION RESULTS WERE NOT OPTIMAL. HOWEVER, THE SURGEON DECIDED TO ACCEPT THE ERROR AND PROCEED WITH THE SURGERY. DURING THE INSPECTION OF THE DEVICE, THE OPTICAL DISTANCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE OPTICAL DISTANCE SENSOR WAS RETRIEVED FOR ANALYSIS AND RECALIBRATION. FOLLOWING RECALIBRATION, IT WAS RETURNED TO THE SITE AND CONFIRMED TO PASS ACCURACY TESTS. THE OPTICAL DISTANCE SENSOR BEING OUT OF CALIBRATION COULD BE A POTENTIAL ROOT CAUSE OF THE EVENT. HOWEVER, OTHER POTENTIAL CONTRIBUTORY ROOT CAUSES WERE ALSO IDENTIFIED: UNDETECTED HEAD MOTION, UNDETECTED MOVEMENT OF THE ANCHOR BOLTS."
        },
        {
          "mdr_text_key": "71882832",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED TO US THAT A PATIENT SUFFERED AN INTRA-OPERATIVE HEMATOMA DURING AN SEEG PROCEDURE. WITHIN A COUPLE HOURS AFTER SURGERY, THE PATIENT HAD ANOTHER EPIDURAL HEMATOMA (NOT AN INTRACEREBRAL HEMORRHAGE) IN THE SAME LOCATION AND HAD TO BE BROUGHT BACK TO THE OR. TWO DAYS AFTER THE SURGERY, A MEDTECH REPRESENTATIVE MET WITH THE SURGEON TO DISCUSS OUTCOMES. THE SURGEON STATED THAT THE PATIENT WAS DOING WELL. THE SURGEON CHOSE TO KEEP THE ELECTRODES IN PLACE, ALL ELECTRODES HAD GOOD SIGNAL: THEY WERE CLOSE ENOUGH TO THEIR TARGETS THAT THEY CAN RECORD THE BRAIN ACTIVITY OF INTEREST."
        }
      ],
      "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": ""
    }
  ]
}