{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "N",
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      "manufacturer_contact_address_1": "",
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        "Followup"
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      "pma_pmn_number": "K101791",
      "date_of_event": "20190314",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "BIOMEDICAL ENGINEER",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "CH",
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      "date_added": "20190409",
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      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20190409",
          "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",
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          "catalog_number": "ROSAP00307",
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          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20190402",
          "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",
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        }
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      "product_problems": [
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        "Break"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "09/11/2019",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "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": "20190409",
          "sequence_number_treatment": [
            ""
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          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20190924",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "8494595",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20190314",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "312105029",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FORCE SENSOR CONNECTION OF DEVICE RO16084 AT SHENZHEN SECOND PEOPLE'S HOSPITAL WAS FOUND BROKEN DURING PRE-OPERATIVE INSPECTION. SURGERY WAS CONVERTED INTO TRADITIONAL SURGERY."
        },
        {
          "mdr_text_key": "312105030",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE CONNECTOR OF THE FORCE SENSOR WAS BROKEN. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE MOST PROBABLE ROOT CAUSE IS THAT AN OVER FORCE WAS APPLIED TO THE CONNECTOR WHILE TRYING TO PULL THECABLE."
        },
        {
          "mdr_text_key": "141307622",
          "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."
        },
        {
          "mdr_text_key": "141307623",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE FORCE SENSOR CONNECTION OF DEVICE RO16084 AT (B)(6) HOSPITAL WAS FOUND BROKEN DURING PRE-OPERATIVE INSPECTION. SURGERY WAS CONVERTED INTO TRADITIONAL SURGERY."
        }
      ],
      "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": "09/24/2019"
    }
  ]
}