SDC Aligners- 100-0352Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00850007728267), received between Jun 22, 2023 and Jan 3, 2024 — classified as 26 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BROKEN TOOTH ON TOOTH #13 (UPPER LEFT PREMOLAR) WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED TO PLACE A CROWN. TREATMENT DISCONTINUATION IS UNKNOWN. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS TOOTH FRACTURE.

  Patient problems: Tooth Fracture

  MAUDE report 18436219 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Wound Infection

  MAUDE report 18394509 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Wound Infection

  MAUDE report 18384436 ↗
• InjuryDec 4, 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 ALIGNERS, MEDICAL INTERVENTION WILL BE REQUIRED. ALIGNERS WERE DISCONTINUED FOR THIS CASE. PATIENT IDENTIFIER IS (B)(6) AND ISSUE ID IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 18262862 ↗
• 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 #8 MEDICAL INTERVENTION WAS 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 18197101 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED ABSCESS ON TOOTH #9 , #10, 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: Wound Infection

  MAUDE report 18178814 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WILL NEED 3 ROOT CANAL ON TEETH 8,9,10 DUE TO AN INFECTION. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Wound Infection

  MAUDE report 18116085 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SHARP NERVE PAIN AND BRUISING OF THE TOOTH #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE 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 17902708 ↗
• 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 #10 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: Necrosis

  MAUDE report 17902703 ↗
• InjurySep 15, 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.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 17760874 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED INFECTION ON LATERAL TOOTH #7 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED.ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS C2EBB5531757BC AND THE COMPLAINT NUMBER IS ID- B)(4).

  Patient problems: Wound Infection

  MAUDE report 17716179 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH LOSS ON UPPER ARCH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTION AND BONE GRAFT WAS PERFORMED. THE CUSTOMER DOES NOT SPECIFIED THE NUMBER OF THE TOOTH. TREATMENT PLAN 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; Tooth Loss

  MAUDE report 17704144 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND A ROOT CANAL WILL BE PERFORMED. THE CUSTUMER DOES NOT DISCONTINUED THE USE OF THE ALIGNERS.FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 17671228 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON FRONT TOOTH #7 WHILE WEARING THE ALIGNERS. 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 17662752 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON FRONT TOOTH #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL WILL BE PERFORMED. THE TREATMENT WAS NOT DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 17662197 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH DAMAGE ON THE UPPER ARCH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTION WAS PERFORMED. THE TREATMENT WAS DISCONTINUED. THE CUSTOMER DOES NOT SPECIFY THE NUMBER OF THE TEETH. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Loss

  MAUDE report 17634081 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON FRONT TOOTH #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL WAS 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 17633657 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE 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 17607786 ↗
• InjuryAug 23, 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 AN 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 17607774 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH # 9 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 17568212 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON UPPER FRONT TOOTH #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND TOOTH #9 WILL NEED A ROOT CANAL. 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 17465079 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #9 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 17400966 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #9 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 17357724 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A TOOTH FRACTURE WHILE WEARING THE ALIGNERS.,THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER.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 17302435 ↗
• InjuryJun 30, 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. 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 17234865 ↗