{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "900 RUE DU MAS DE VERCHANT",
      "event_location": "",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "FL",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON",
      "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE",
      "manufacturer_contact_pcity": "90474144",
      "event_type": "Injury",
      "report_number": "3009185973-2021-00157",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20210624",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K192173",
      "date_of_event": "20210527",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "32218",
      "reporter_occupation_code": "BIOMEDICAL ENGINEER",
      "manufacturer_contact_plocal": "9047414400",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "SHARMA",
      "source_type": [
        "Distributor"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "34000",
      "manufacturer_g1_state": "",
      "reporter_country_code": "CH",
      "manufacturer_contact_area_code": "904",
      "date_added": "20210624",
      "manufacturer_contact_f_name": "JAY",
      "device_date_of_manufacturer": "20200918",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "958425",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20210624",
          "brand_name": "ROSA ONE",
          "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 ONE 3.1",
          "catalog_number": "ROSAS00205",
          "lot_number": "3.1.4.1650",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "OLO",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Computer Software Problem",
        "Computer Software Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "11/30/2021",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250807",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "9047",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20210624",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20211130",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "FR",
      "manufacturer_contact_city": "JACKSONVILLE",
      "mdr_report_key": "12056045",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210527",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "34000",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MEDTECH SA",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "326962233",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT STARTING UP THE ROSA ONE SYSTEM BEFORE THE SURGERY AND FIND THAT ROSA CANNOT ACCESS THE ROSA SPINE INTERFACE, TO START BUILDING THE PATIENT FOLDER. THE SURGERY WAS CONVERTER TO A TRADITIONAL SURGERY."
        },
        {
          "mdr_text_key": "326962234",
          "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. ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DATA COULD NOT BE RETRIEVED. DUE TO COVID-19 SITUATION, IT IS UNKNOWN WHEN THE DATA WILL BE ACCESSIBLE. THIS COMPLAINT COULD BE RE-OPENED IF THE DATA BECOMES AVAILABLE. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G3 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE. - H4 DEVICE MANUFACTURER DATE. - H6 ADVERSE EVENT PROBLEM. - H10 ADDITIONAL NARRATIVES/DATA."
        },
        {
          "mdr_text_key": "258022120",
          "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": "258022121",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT STARTING UP THE ROSA ONE SYSTEM BEFORE THE SURGERY AND FIND THAT ROSA CANNOT ACCESS THE ROSA SPINE INTERFACE, TO START BUILDING THE PATIENT FOLDER. THE SURGERY WAS CONVERTER TO A TRADITIONAL SURGERY."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "ZAC EUREKA",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "32218",
      "manufacturer_contact_exchange": "904",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "11/30/2021"
    }
  ]
}