{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "IRVINE",
      "manufacturer_contact_address_1": "2144 MICHELSON DRIVE",
      "manufacturer_contact_pcity": "94922235",
      "event_type": "Injury",
      "report_number": "3011649314-2026-00469",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260331",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K143353",
      "date_of_event": "20260211",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "92612",
      "reporter_occupation_code": "DENTIST",
      "manufacturer_contact_plocal": "9492223590",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "GALLUP",
      "source_type": [
        "Health Professional"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "92612",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "949",
      "date_added": "20260331",
      "manufacturer_contact_f_name": "SHELLY",
      "device_date_of_manufacturer": "20250916",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "260551",
          "implant_date_year": "2025",
          "date_removed_year": "2026",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260331",
          "brand_name": "GLIDEWELL HT IMPLANT Ø3.5 X 10 MM",
          "generic_name": "GLIDEWELL HT IMPLANT SYSTEM",
          "manufacturer_d_name": "PRISMATIK DENTALCRAFT, INC.",
          "manufacturer_d_address_1": "2144 MICHELSON DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "IRVINE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92612",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92612",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "70-1189-IMP0005",
          "catalog_number": "70-1189-IMP0005",
          "lot_number": "6275038",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "DZE",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Implant, Endosseous, Root-Form",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3640",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Failure to Osseointegrate"
      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260331",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "9492",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260331",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "67 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Failure of Implant"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260330",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "IRVINE",
      "mdr_report_key": "24737919",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260325",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Repair"
      ],
      "manufacturer_g1_zip_code": "92612",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "PRISMATIK DENTALCRAFT, INC.",
      "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": "397068425",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. MANUFACTURER REFERENCE: (B)(4)."
        },
        {
          "mdr_text_key": "397068426",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DR. (B)(6) REPORTED THAT A GLIDEWELL HT IMPLANT FAILED. THE PATIENT PRESENTED ON (B)(6) 2025 FOR A PRIMARY PROCEDURE ON TOOTH #5. ON (B)(6) 2026 THE PROVIDER DETERMINED THAT THE IMPLANT FAILED TO OSSEOINTEGRATE AND REMOVED THE IMPLANT. THE PATIENT'S BONE QUALITY IS TYPE IV AND THEIR ORAL HYGIENE IS GOOD. PER THE REPORTED INFORMATION, THE PATIENT HAS NO RELEVANT MEDICAL HISTORY. NO INJURY WAS REPORTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "2144 MICHELSON DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "92612",
      "manufacturer_contact_exchange": "949",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}