{
  "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": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K200511",
      "date_of_event": "20210402",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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        "HEALTH"
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20210430",
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      "device": [
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          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
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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": "",
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          "udi_public": "",
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        "Computer Software Problem"
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      "reporter_state_code": "MA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/16/2021",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250803",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
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          "date_received": "20210430",
          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          "patient_age": "",
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          "patient_weight": "",
          "patient_ethnicity": "",
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          "patient_problems": [
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            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210618",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11751911",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210402",
      "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": "324840057",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A DETAILED ANALYSIS OF THE DATA LOGS AND PATIENT FILE HAS BEEN PERFORMED AND REVEALED THAT THE INACCURATE RESULT OF THE AUTOMATIC FUSION WAS DUE TO THE FACT THAT THE MRI WAS USED AS REFERENCE EXAM, AND THE CT SCAN WAS MERGED TO IT. IT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE TO USE THE CT SCAN AS A 3D REFERENCE EXAM. IF THE RESULT OF THE AUTOMATIC FUSION IS UNSATISFYING, MANUAL ADJUSTMENTS SHOULD BE PERFORMED, AS RECOMMENDED IN THE IFUS. REVIEW OF THE LOGFILES INDICATED THAT NO MANUAL ADJUSTMENT WAS PERFORMED DURING THE SUBJECT SURGERY. THE INSTRUCTIONS FOR USE ADEQUATELY SPECIFY THE LOADING ORDER FOR PERFORMING AN AUTOMATIC FUSION BETWEEN CT AND MRI."
        },
        {
          "mdr_text_key": "324840058",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE NEUROLOGIST NOTED THAT MERGE SEEMED INACCURATE WHILE CONFIRMING PLAN, REQUIRED RE-MERGE OF IMAGING. DELAY OF 30 MINUTES."
        },
        {
          "mdr_text_key": "248160119",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED."
        },
        {
          "mdr_text_key": "248160120",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE NEUROLOGIST NOTED THAT MERGE SEEMED INACCURATE WHILE CONFIRMING PLAN, REQUIRED RE-MERGE OF IMAGING. DELAY OF 30 MINUTES."
        }
      ],
      "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": "06/18/2021"
    }
  ]
}