{
  "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": "3009185973-2020-00195",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200826",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K192173",
      "date_of_event": "20200727",
      "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": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200826",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "918347",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20200826",
          "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": "SPINE SHORT ADAPTOR",
          "catalog_number": "ROSAS00112",
          "lot_number": "ROSA3-117B",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "OLO",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "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": [
        "Mechanical Jam",
        "Mechanical Jam"
      ],
      "reporter_state_code": "IN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/23/2021",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "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": "20200826",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Information",
            "No Clinical Signs, Symptoms or Conditions",
            "No Information",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210625",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10452787",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200727",
      "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": "204387345",
          "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. UDI#: UNKNOWN."
        },
        {
          "mdr_text_key": "204387346",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE 6MM CANNULA BECAME STUCK INSIDE THE DRILL ADAPTER, WHICH THE SURGEON USED A MALLET TO PASS THE CANNULA THROUGH THE DRILL ADAPTER. THIS RESULTED IN A \"SKIVED\" TRAJECTORY."
        },
        {
          "mdr_text_key": "324633738",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE 6MM CANNULA BECAME STUCK INSIDE THE DRILL ADAPTER, WHICH THE SURGEON USED A MALLET TO PASS THE CANNULA THROUGH THE DRILL ADAPTER. THIS RESULTED IN A \"SKIVED\" TRAJECTORY."
        },
        {
          "mdr_text_key": "324633739",
          "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. IT WAS REPORTED THAT DURING A SURGERY, THE 6MM CANNULA BECAME STUCK INSIDE THE ADAPTER, WHICH THE SURGEON USED A MALLET TO PASS THE CANNULA THROUGH THE DRILL ADAPTER. THIS RESULTED IN A \"SKIVED\" TRAJECTORY AND THE SURGERY WAS CONVERTED INTO A TRADITIONAL SURGERY. DEVICE WAS NOT RETURNED AT MANUFACTURING SITE DESPITE SEVERAL ATTEMPTS. THIS IS A KNOW ISSUE THAT HAS ALREADY BEEN REPORTED AND INVESTIGATED THROUGH CONTINUOUS IMPROVEMENT OF THE DEVICE. A NEW DESIGN OF THE PART WAS DEVELOPPED AND WAS DISTRIBUTED TO THE CUSTOMER. D4: UDI#: (B)(4). H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER."
        }
      ],
      "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": "06/25/2021"
    }
  ]
}