{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "N",
      "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": "3009185973-2021-00060",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20210224",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K200511",
      "date_of_event": "20210203",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "COMPANY REPRESENTATIVE",
        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "CA",
      "manufacturer_contact_area_code": "",
      "date_added": "20210224",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "271597",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20210224",
          "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",
          "catalog_number": "ROSAS00216",
          "lot_number": "3.1.4.1650",
          "other_id_number": "",
          "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"
          }
        }
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      "product_problems": [
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        "Data Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "08/03/2021",
      "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": "20210224",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210803",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11371748",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210203",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "325855973",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SURGEON NOTED THAT TRAJECTORY PLACEMENT SEEMED INCORRECT - CONCERNED THAT EXPORT WAS INCORRECT. SURGEON RE-OPENED LAPTOP TO CONFIRM THAT TRAJECTORY PLACEMENT WAS CORRECTLY PLANNED ON PLANNING SOFTWARE. SURGEON NOTED THAT HE BELIEVED THAT PLANNING HAD NOT SAVED PROPERLY, BUT IT MIGHT BE POSSIBLE THAT HE FORGOT TO SAVE PRIOR TO EXPORT. SURGEON CONFIRMED TRAJECTORIES BEFORE PROCEEDING, DELAY 15 MINUTES."
        },
        {
          "mdr_text_key": "325855974",
          "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. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS DID NOT SHOW ANY ISSUE DURING EXPORT OR IMPORT OF THE PATIENT FOLDER. THIS COULD BE CONSISTENT WITH THE SUGGESTION MADE IN THE COMPLAINT DESCRIPTION: THE USER COULD HAVE FORGOTTEN TO SAVE BEFORE EXPORT, BUT THIS HYPOTHESIS COULD NOT BE CONFIRMED WITH THE DATA. THE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED."
        },
        {
          "mdr_text_key": "233264453",
          "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. UNIQUE IDENTIFIER (UDI) #: (B)(4)."
        },
        {
          "mdr_text_key": "233264454",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "SURGEON NOTED THAT TRAJECTORY PLACEMENT SEEMED INCORRECT - CONCERNED THAT EXPORT WAS INCORRECT. SURGEON RE-OPENED LAPTOP TO CONFIRM THAT TRAJECTORY PLACEMENT WAS CORRECTLY PLANNED ON PLANNING SOFTWARE. SURGEON NOTED THAT HE BELIEVED THAT PLANNING HAD NOT SAVED PROPERLY, BUT IT MIGHT BE POSSIBLE THAT HE FORGOT TO SAVE PRIOR TO EXPORT. SURGEON CONFIRMED TRAJECTORIES BEFORE PROCEEDING, DELAY 15 MINUTES."
        }
      ],
      "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": "08/03/2021"
    }
  ]
}