{ "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": 660 } }, "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": "Malfunction", "report_number": "3011649314-2025-00003", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250103", "manufacturer_address_2": "", "pma_pmn_number": "K183270", "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": "20250103", "manufacturer_contact_f_name": "SHELLY", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1604789", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250103", "brand_name": "EXTRA SILENT NITE SL", "generic_name": "SILENT NITE SLEEP APPLIANCE", "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": "LAY USER/PATIENT", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LRK", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Device, Anti-Snoring", "medical_specialty_description": "Dental", "regulation_number": "872.5570", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;10/04/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20251223", "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": "20250103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251017", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "21074136", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241211", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92612", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "PRISMATIK DENTALCRAFT, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "361246635", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE: COMP-(B)(4)." }, { "mdr_text_key": "361246636", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AN EXTRA SILENT NITE SL APPLIANCE HAS BROKEN. IT WAS REPORTED THAT THE BUTTONS THAT HOLD THE ELASTICS KEEP BREAKING OFF. NO INJURY WAS REPORTED." }, { "mdr_text_key": "388375957", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE PRODUCTION RECORD FOR THE CASE NUMBER WAS REVIEWED, AND NO ANOMALIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION: BASED ON THE COMPLAINT DESCRIPTION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED; HOWEVER, IT IS PLAUSIBLE THAT THE APPLIANCE FAILURE RESULTED FROM NORMAL WEAR AND USE OVER TIME. MANUFACTURER REFERENCE: (B)(4)." }, { "mdr_text_key": "387877127", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MANUFACTURER PREVIOUSLY REPORTED INCORRECT INFORMATION . THE FOLLOWING CORRECTION HAS BEEN UPDATED IN THIS REPORT. CORRECTED INFORMATION G3(DATE RECEIVED BY MANUFACTURER) THAT WAS NOT CAPTURED IN THE PERVIOUS REPORT WAS CORRECTED IN THIS REPORT. MANUFACTURER REFERENCE: (B)(4)." } ], "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": "10/07/2025;10/17/2025" } ] }