{
  "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": "*",
      "manufacturer_contact_t_name": "",
      "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": "3009185973-2017-00753",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20171108",
      "manufacturer_address_2": "",
      "pma_pmn_number": "PK101791",
      "date_of_event": "20171011",
      "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_contact_l_name": "",
      "source_type": [
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        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20171108",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "790754",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20171108",
          "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": "",
          "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 2.5.8",
          "catalog_number": "N/A",
          "lot_number": "",
          "other_id_number": "N/A",
          "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",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Device Difficult to Setup or Prepare",
        "Device Difficult to Setup or Prepare"
      ],
      "reporter_state_code": "GA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/27/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250825",
      "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": "20171108",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7008643",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20171011",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Inspection"
      ],
      "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": "250756215",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT PATIENT COULD NOT BE REGISTERED WITH OPTICAL DISTANCE SENSOR, AND SURGEON HAD TO CHANGE TO BONE FIDUCIALS REGISTRATION TO BE ABLE TO CONTINUE SURGERY. SKIN DEFORMATION WAS THE MAJOR CONTRIBUTOR TO THE POOR REGISTRATION QUALITY, BUT THIS INFORMATION CANNOT BE VERIFIED AS NO PHOTOS OF THE PATIENT WERE AVAILABLE. THE REDUCED SCANNING ZONE MAY HAVE ALSO CONTRIBUTED TO THE POOR REGISTRATION QUALITY. THE REGISTRATION DID NOT FAIL AS THEY WERE ALL USER CANCELLED DUE TO WARNINGS PRESENT IN THE SOFTWARE. THE ROBOT DID NOT MALFUNCTION."
        },
        {
          "mdr_text_key": "91289931",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE RO14031 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": "91289932",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE REGISTRATION PERFORMED WITH THE OPTICAL DISTANCE SENSOR WAS NOT ACCURATE ENOUGH TO PROCEED WITH THE SURGERY, DESPITE THE THREE REGISTRATION ATTEMPTS. FINALLY, AFTER 2.5 HOURS DELAY, THE SURGEON DECIDED TO PERFORM REGISTRATION WITH BONE FIDUCIALS, REQUIRING TO PERFORM A NEW SCAN EXAM FOR THE PATIENT. THIS REGISTRATION METHOD WAS PERFORMED WITH NO PROBLEMS AND ENABLED TO PERFORM THE CASE."
        }
      ],
      "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": "04/27/2018"
    }
  ]
}