sequential aligner 100-0352Recalls & reported problems

Summary

The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 00850007728007), received between Jul 5, 2021 and Jan 8, 2024 — classified as 322 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 25 most recent of 322 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED INFECTION WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED TO PERFORM A ROOT CANAL ON TOOTH #8. TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis; Wound Infection

  MAUDE report 18471955 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH FRACTURED, MEDICAL INTERVENTION WAS REQUIRED, TOOTH EXTRACTION WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 18179041 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH LOSS #22 WHILE WEARING THE ALIGNERS. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18116067 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TEETH (#12, #26) WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND ROOT CANAL WAS PERFORMED. ALIGNERS WERE DISCONTINUED FOR THIS CASE. PATIENT IDENTIFIER IS (B)(6) AND ISSUE ID IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 18007992 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #19 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND 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 17902709 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH FRACTURE ON TOOTH #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTION WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 17742410 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED EXTRACTED BACK TOOTH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTED TOOTH WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Loss

  MAUDE report 17608090 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TEETH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL WILL BE PERFORMED. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. IT IS UNKNOWN IF 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 17577710 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CRACK ON TOOTH #3 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND TOOTH #3 WAS REMOVED..THE TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 17503621 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DAMAGE ON TOOTH #14 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND AN EXTRACTION WILL BE PERFORMED. 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 17435698 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #8 WHILE WEARING THE ALIGNERS. ALIGNER TREATMENT WAS NOT DISCONTINUE. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL WILL BE PERFORMED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 17346432 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #24 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL WILL BE 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 17175338 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NECROSIS ON TOOTH #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND ROOT CANAL WILL BE 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 17140227 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED INFECTION ON TEETH #24 ADN #25 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND GUM GRAFT WILL BE PERFORMED. ALIGNER TREATMENT WAS NOT DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Wound Infection

  MAUDE report 17131302 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BONE LOSS WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A BONE GRAFT AND GUM GRAFTS WERE PERFORMED. ALIGNER TREATMENT WAS COMPLETED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17130650 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED LOSS OF TOOTH #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Loss

  MAUDE report 17129822 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #20 BROKE WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND THE TOOTH WAS EXTRACTED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 17101115 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #12 WHILE WEARING THE ALIGNERS. 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 17043823 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH LOSS ON #12 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND THE EXTRACTION WAS PERFORMED. IT IS UNKNOWN IF THE ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER (B)(4).

  Patient problems: Tooth Loss

  MAUDE report 16877406 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH MOBILITY ON #25 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND AN IMPLANT WILL BE PLACED. ALIGNER TREATMENT HAS BEEN COMPLETED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16877372 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CRACKED MOLAR WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION WAS REQUIRED, AND THE TOOTH WAS EXTRACTED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 16817100 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN MOLAR WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION IS REQUIRED, AND THE TOOTH WILL BE EXTRACTED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 16788367 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #20 CRACKED WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL AND A CROWN WILL BE PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 16702336 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL NEEDS TO BE PERFORMED. IT IS UNKNOWN IF 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 16690869 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NECROSIS ON TOOTH #9 WHILE WEARING THE ALIGNERS. 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 16658439 ↗