SDC ALIGNERS MCC 100-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850007728274), received between May 12, 2023 and Dec 27, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Tooth Loss

  MAUDE report 18399526 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BONE LOSS ON ANTERIOR TEETH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED TO EXTRACT TEETHS #24 AND #25. 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 Fracture

  MAUDE report 18372502 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN ABSCESS WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE 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: Wound Infection

  MAUDE report 17902707 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH FRACTURE ON A LOWER TOOTH WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND A ROOT CANAL WILL BE 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 Fracture

  MAUDE report 17611342 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT #4 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 17174943 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE WHILE WEARING THE ALIGNERS ON TOOTH #24. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL 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: Necrosis

  MAUDE report 17167457 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED GUM RECESSION WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION IS REQUIRED, AND GUM GRAFT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17131684 ↗
• InjuryMay 12, 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 NEEDS TO BE PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS ID-(B)(4).

  Patient problems: Necrosis

  MAUDE report 16924218 ↗