{
  "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": "N",
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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",
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      "type_of_report": [
        "Initial submission",
        "Followup"
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K101791",
      "date_of_event": "20190318",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
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        "HEALTH"
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      "manufacturer_g1_state": "",
      "reporter_country_code": "GM",
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      "date_added": "20190410",
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      "device": [
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          "device_event_key": "",
          "implant_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20190410",
          "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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          "device_operator": "HEALTH PROFESSIONAL",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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        "Computer Software Problem"
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/20/2019",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "sequence_number_treatment": [
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          "patient_age": "",
          "patient_sex": "",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20190621",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "8499451",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20190318",
      "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",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "312104686",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE SURGEON STATED THAT THE AUTOMATIC FUSION OF THE MRI AND CT WAS NOT WORKING PROPERLY. FINALLY FUSION WAS PERFORMED MANUALLY AND THE SURGERY WAS CONTINUED."
        },
        {
          "mdr_text_key": "312104687",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE SURGEON STATED THAT THE AUTOMATIC FUSION WAS NOT WORKING PROPERLY. THE DATA AVAILABLE FOR INVESTIGATION WAS INSUFFICIENT. HOWEVER REPORTEDLY, THE USER FINALLY ADJUSTED THE FUSION MANUALLY WHICH ENABLED HIM TO PERFORM THE SURGERY. AS INDICATED IN THE USER MANUAL, THE MERGE FEATURE DOES NOT ALWAYS PROVIDE SATISFYING RESULTS, HENCE THE EXISTENCE OF A FUSION ADJUSTMENT INTERFACE. THE USER MANUAL PROVIDES ALL NECESSARY INFORMATION ABOUT AVAILABLE ADJUSTMENTS TO OBTAIN AN ACCURATE IMAGE FUSION. THE EVENT REPORTED IN THIS COMPLAINT WAS NOT DUE TO A DEVICE MALFUNCTION, THE DEVICE WORKED AS EXPECTED. H3 OTHER TEXT : NO DATA AVAILABLE FOR INVESTIGATION."
        },
        {
          "mdr_text_key": "141462183",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)."
        },
        {
          "mdr_text_key": "141462184",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE SURGEON STATED THAT THE AUTOMATIC FUSION OF THE MRI AND CT WAS NOT WORKING PROPERLY. FINALLY FUSION WAS PERFORMED MANUALLY AND THE SURGERY WAS CONTINUED."
        }
      ],
      "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": "07/18/2019"
    }
  ]
}