{
  "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": "2026-08-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "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": "2020467-2020-00002",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20201020",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K192119",
      "date_of_event": "20200901",
      "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": [
        "FOREIGN",
        "HEALTH PROFESSIONAL"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20201020",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1167386",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20201020",
          "brand_name": "3M CLARITY ALIGNERS",
          "generic_name": "ALIGNER, SEQUENTIAL",
          "manufacturer_d_name": "3M HEALTH CARE",
          "manufacturer_d_address_1": "2510 CONWAY AVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ST. PAUL",
          "manufacturer_d_state": "MN",
          "manufacturer_d_zip_code": "55144",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "55144",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20230327",
          "model_number": "358-455",
          "catalog_number": "358-455",
          "lot_number": "VBM8702",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NXC",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00652221236463",
          "udi_public": "00652221236463",
          "openfda": {
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Insufficient Device Problem Information",
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250810",
      "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": "20201020",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "43 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Sensitivity of Teeth",
            "Sensitivity of Teeth"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20201020",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10708618",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201005",
      "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": "212268319",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "PATIENT INFORMATION: NO INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 3M WILL CONTINUE TO MONITOR."
        },
        {
          "mdr_text_key": "212268320",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "AN ORTHODONTIST REPORTED THAT A PATIENT HAD A ROOT CANAL PERFORMED ON TOOTH #10 AFTER DIFFICULTY EXPERIENCED WITH REMOVAL OF A 3M CLARITY ALIGNER AFTER OVERNIGHT WEAR. THE PATIENT CONTINUED TO WEAR THE ALIGNER AND TOOTH #10 TURNED GREY WITHIN THE FIRST WEEK OF WEAR. THE PATIENT VISITED AN ENDODONTIST AND THE TOOTH WAS OBSERVED FOR A FEW WEEKS, AFTER WHICH A ROOT CANAL WITH INTERNAL BLEACHING WAS PERFORMED. A COMPOSITE ON THE LINGUAL SIDE IS PLANNED."
        }
      ],
      "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": ""
    }
  ]
}