{
  "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": 4
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "TN",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "ANTIOCH",
      "manufacturer_contact_address_1": "1530 ANTIOCH PIKE",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3032193293-2026-00001",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260507",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K212496",
      "date_of_event": "20260407",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "KESSLER",
      "source_type": [
        "Consumer"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "37013",
      "manufacturer_g1_state": "TN",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260507",
      "manufacturer_contact_f_name": "JOSH",
      "device_date_of_manufacturer": "20260219",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1172592",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20260507",
          "brand_name": "SMILESET",
          "generic_name": "SMILESET ALL-DAY ALIGNERS",
          "manufacturer_d_name": "ORTHO DENTAL LAB, LLC",
          "manufacturer_d_address_1": "1530 ANTIOCH PIKE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ANTIOCH",
          "manufacturer_d_state": "TN",
          "manufacturer_d_zip_code": "37013",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "37013",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "121-0106",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "NXC",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Inadequacy of Device Shape and/or Size"
      ],
      "reporter_state_code": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260508",
      "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": "20260507",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "34 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Tooth Fracture"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260507",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "ANTIOCH",
      "mdr_report_key": "25113823",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260407",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "37013",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "ORTHO DENTAL LAB, LLC",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "400599849",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE SMILESET ALL-DAY ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS A MDR AS THE PATIENT REPORTED A BROKEN TOOTH WHILE A SMILESET ALL-DAY ALIGNER WAS BEING USED."
        },
        {
          "mdr_text_key": "400599850",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "CUSTOMER ALLEGED THAT THE ALIGNERS DID NOT FIT THEIR TEETH PROPERLY AND ALLEGEDLY CAUSED ONE OF THEIR TEETH TO BREAK. CUSTOMER STATED THEY ARE NOW GOING TO HAVE AN IMPLANT PLACED AND REQUESTED TO RETURN THE ALIGNERS."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "1530 ANTIOCH PIKE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}