{
  "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": "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": "3009185973-2018-00169",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20180606",
      "manufacturer_address_2": "",
      "pma_pmn_number": "PK101791",
      "date_of_event": "20180605",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "HEALTH PROFESSIONAL"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "FR",
      "manufacturer_contact_area_code": "",
      "date_added": "20180606",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "414842",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180606",
          "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": "COMPUTER FOR PRE OP PLANNING",
          "catalog_number": "N/A",
          "lot_number": "N/A",
          "other_id_number": "N/A",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20181126",
          "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": [
        "Electrical Power Problem",
        "Electrical Power Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "12/05/2018",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "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": "20180606",
          "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": "20181221",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7573315",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180605",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Replace"
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "110249285",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE 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": "110249286",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "SURGEON CALLED THE FIELD SERVICE ENGINEER BECAUSE SHE NEEDED TECHNICAL ASSISTANCE ABOUT THE PLANNING PC. THIS WAS IMPOSSIBLE TO CHARGE WITH THE ASSOCIATED POWER SUPPLY CORD. THE FIELD SERVICE ENGINEER ASKED HER TO CHECK ALL PART OF THE POWER CORD, TEST THE GOOD FUNCTIONING OF THE WALL OUTLET. THE POWER IS SUSPECTED TO BE NON-USABLE."
        },
        {
          "mdr_text_key": "310463829",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE COMPUTER FOR PRE OP PLANNING CHARGER WAS NOT FUNCTIONING. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TESTING AT MANUFACTURING SITE, THE CHARGER CANNOT BE USED ANYMORE. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS AN ELECTRICAL ISSUE OR A NORMAL WEAR OF THE CHARGER. NO FURTHER INFORMATION PERMITS TO CONCLUDE ABOUT THE ROOT CAUSE OF THIS EVENT. CORRECTED DATA: DATE OF THIS REPORT. DEVICE AVAILABILITY. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVENT PROBLEM AND EVALUATION CODE. REMEDIAL ACTION."
        },
        {
          "mdr_text_key": "310463830",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SURGEON CALLED THE FIELD SERVICE ENGINEER BECAUSE SHE NEEDED TECHNICAL ASSISTANCE ABOUT THE PLANNING PC. THIS WAS IMPOSSIBLE TO CHARGE WITH THE ASSOCIATED POWER SUPPLY CORD. THE FIELD SERVICE ENGINEER ASKED HER TO CHECK ALL PART OF THE POWER CORD, TEST THE GOOD FUNCTIONING OF THE WALL OUTLET. THE POWER IS SUSPECTED TO BE NON-USABLE."
        }
      ],
      "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": "12/21/2018"
    }
  ]
}