{
  "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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    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
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      "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": "3009185973-2022-00003",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20220127",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K200511",
      "date_of_event": "20220110",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "32218",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "9047414400",
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      "manufacturer_contact_l_name": "SHARMA",
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      "distributor_zip_code_ext": "",
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      "manufacturer_contact_f_name": "JAY",
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "763687",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20220127",
          "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": "",
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          "device_availability": "Yes",
          "device_report_product_code": "HAW",
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          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250821",
      "health_professional": "Y",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "9047",
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          "date_received": "20220127",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hemorrhage/Blood Loss/Bleeding",
            "Hemorrhage/Blood Loss/Bleeding"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220121",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "FR",
      "manufacturer_contact_city": "JACKSONVILLE",
      "mdr_report_key": "13364082",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220111",
      "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": "284511879",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "A DETAILED ANALYSIS OF SOFTWARE LOGS AND PATIENT FILES WAS PERFORMED AND CONFIRMED INACCURACIES OF THE ELECTRODES PLACEMENT AT THE ENTRY POINTS AND/OR TARGET POINTS. THE INACCURACY AT THE ENTRY POINT IS CONFIRMED FOR SEVEN ELECTRODES OUT OF THIRTEEN IMPLANTED. THREE ELECTRODES WERE ALSO IMPLANTED DEEPER THAN EXPECTED. THE ELECTRODE DEPTH INSIDE THE BRAIN DEPENDS ON THE METHOD OF IMPLANTATION. AN ERROR IN THE REGISTRATION WORKFLOW WAS MADE, BUT GLOBALLY, REGISTRATION WAS PERFORMED PROPERLY. NO ROBOTIC OR FUNCTIONAL ERROR WAS FOUND, AND THE ANALYSIS SUGGESTS THAT THE DEVICE BEHAVED AS EXPECTED. A PREVENTIVE MAINTENANCE WAS PERFORMED ON THE DEVICE FOLLOWING THIS EVENT AND ALL TESTS PASSED. NO ROOT CAUSE COULD BE CONCLUSIVELY DETERMINED FOR THE OBSERVED INACCURACIES. UDI# : (B)(4)."
        },
        {
          "mdr_text_key": "284511880",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED BY A SURGEON THAT FOLLOWING A SURGERY THAT OCCURRED ON (B)(6) 2022 IT WAS NOTICED THAT THE TRAJECTORIES OF THE ELECTRODES WERE NOT ACCURATE AND CAUSED A SUBDURAL HEMORRHAGE. THE PATIENT IS CLINICALLY STABLE."
        }
      ],
      "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": ""
    }
  ]
}