NIGHTTIME ALIGNERS - REF 100-0364Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007728328), received between Aug 7, 2023 and Dec 20, 2023 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED "THE ALIGNERS CAUSED HER TEETH TO BRUISE AND SHE HAS TO DO RCT". MEDICAL INTERVENTION COULD BE REQUIRED, AND ROOT CANAL COULD BE PERFORMED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 18369975 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #10, MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 18197097 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED ROOT CANAL WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND IS THE THIRD ROOT CANAL PERFORMED. THE CUSTUMER DOES NOT SPECIFY TOOTH NUMBER.THE TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 17473396 ↗