{
  "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": "",
      "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": "MAUGUIO, LANGUEDOC-ROUSSILLON",
      "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE",
      "manufacturer_contact_pcity": "90474144",
      "event_type": "Injury",
      "report_number": "3009185973-2022-00011",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20220216",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K192173",
      "date_of_event": "20220128",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "32218",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "9047414400",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "SHARMA",
      "source_type": [
        "Health Professional",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "34130",
      "manufacturer_g1_state": "",
      "reporter_country_code": "FR",
      "manufacturer_contact_area_code": "904",
      "date_added": "20220216",
      "manufacturer_contact_f_name": "JAY",
      "device_date_of_manufacturer": "20170227",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "537751",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20220216",
          "brand_name": "ROSA ONE",
          "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE",
          "manufacturer_d_name": "MEDTECH SAS",
          "manufacturer_d_address_1": "432 RUE DU RAJOL",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "34130",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "34130",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "ROSA ONE 3.1",
          "catalog_number": "ROSAS00201",
          "lot_number": "3.1.5.28",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "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": [
        "Electrical /Electronic Property Problem",
        "Electrical /Electronic Property Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250803",
      "health_professional": "",
      "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": "20220216",
          "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": "20220216",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "FR",
      "manufacturer_contact_city": "JACKSONVILLE",
      "mdr_report_key": "13540129",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220128",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "34130",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MEDTECH SAS",
      "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": "288026352",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE SCREEN OF THE ROBOT DID NOT TURN ON, SO IT WAS NOT USABLE FOR A BRAIN BIOPSY."
        },
        {
          "mdr_text_key": "288026353",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "TESTS WERE DONE REMOTELY TO SOLVE THIS ISSUE. THERE WAS NO DISPLAY ON THE SCREEN EVEN THOUGH IT WAS WELL POWERED (POWER LIGHT ON). THE SURGEON RESTARTED THE SYSTEM, THIS TIME BY CONNECTING THE CAMERA STAND AND THERE THE DISPLAY ON THE SCREEN REAPPEARED. FINALLY THE SURGEON RESTARTED THE ROSA ROBOT ALONE, WITHOUT THE CAMERA CONNECTED, AND EVERYTHING WORKED. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT WOULD BE AN ELECTRICAL ISSUE, BUT THIS CANNOT BE CONFIRMED. UNIQUE IDENTIFIER (UDI) #: (B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "432 RUE DU RAJOL",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "32218",
      "manufacturer_contact_exchange": "904",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}