{
  "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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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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        "Followup"
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      "pma_pmn_number": "PK101791",
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      "manufacturer_contact_zip_code": "",
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          "serviced_by_3rd_party_flag": "",
          "date_received": "20180504",
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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": "",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "34000",
          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "ROSA SOFTWARE",
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          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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        "Display or Visual Feedback Problem"
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      "suppl_dates_mfr_received": "10/05/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250808",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
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      "patient": [
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          "date_received": "20180504",
          "sequence_number_treatment": [
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          "patient_age": "",
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          "patient_weight": "",
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          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20181009",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7486198",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180501",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
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      "adverse_event_flag": "Y",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "107316806",
          "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."
        },
        {
          "mdr_text_key": "107316807",
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        },
        {
          "mdr_text_key": "309035415",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A MERGE FAILURE OCCURRED WHEN THE SURGEON ATTEMPTED TO MERGE EXAMS. A DHR AND A COMPLAINT HISTORY REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A TEST WAS PERFORMED AT THE MANUFACTURING SITE AND CONCLUDED THAT NO NOTICEABLE ISSUE OCCURED. THE MERGE ISSUE DESCRIBED IN THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED."
        }
      ],
      "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": "10/09/2018"
    }
  ]
}