RETAINER KIT 100-0354Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00850007728038), received between Sep 1, 2021 and Dec 4, 2023 — classified as 42 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 42 reports, in the reporter's own words as published by the FDA.

• 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 #9 WHILE WEARING RETAINERS, MEDICAL INTERVENTION WAS REQUIRED, AND A 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 18263183 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH #7 LOOSE AND BONE LOSS WHILE WEARING RETAINERS, MEDICAL INTERVENTION WAS REQUIRED, AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18262650 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #22, MEDICAL INTERVENTION WAS REQUIRED, AND A 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 18096799 ↗
• InjuryNov 7, 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 A ROOT CANAL WAS PERFORMED. ALIGNERS WERE DISCONTINUED FOR THIS CASE. PATIENT IDENTIFIER IS (B)(6) AND ISSUE ID IS (B)(6).

  Patient problems: Necrosis

  MAUDE report 18081611 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TEETH #11, #12 WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND 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 18059541 ↗
• 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 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 17661099 ↗
• InjuryAug 28, 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. 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: Necrosis

  MAUDE report 17632763 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON FRONT LEFT TOOTH WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND A ROOT CANAL 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 17589411 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A ROOT CANAL ON TOOTH #10 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND 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 17560309 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH LOSS ON TEETH #10 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WILL BE REQUIRED, AND AN IMPLANT 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: Tooth Loss

  MAUDE report 17483905 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED INFECTION ON BOTTOM FRONT TWO TEETH #24 AND #25 WHILE WEARING THE RETAINERS. THE TREATMENT WAS DISCONTINUED. MEDICAL INTERVENTION IS REQUIRED, AND 24 AND 25TH TEETH REMOVED AND NOW THE CUSTOMER IS WAITING FOR A BRIDGE TO BE PLACED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Wound Infection

  MAUDE report 17400489 ↗
• InjuryJan 31, 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 RETAINERS. MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL NEEDS TO BE PERFORMED. RETAINER 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 16273810 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED MOBILITY ON TOOTH #9 WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTION WAS PERFORMED. RETAINER USAGE 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 16174463 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH LOSS ON #5 WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION WAS REQUIRED. RETAINER 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 15834689 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN IMPLANT ON #29 AND A CRACKED MOLAR ON #14 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND AN EXTRACTION OF THE IMPLANT AND A ROOT CANAL WERE 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; Tooth Fracture

  MAUDE report 15374819 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON #18 AND #31 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND ROOT CANALS WERE 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 15351536 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #3 BROKE WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION IS REQUIRED. RETAINER USAGE WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 15342102 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH NECROSIS ON #12 #13 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND ROOT CANALS WERE PERFORMED. IT IS UNKNOWN IF RETAINER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 15341677 ↗
• InjuryAug 26, 2022Adverse 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 RETAINERS. MEDICAL INTERVENTION WAS REQUIRED AND A ROOT CANAL WAS PERFORMED. RETAINER USAGE WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 15307091 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #14 BROKE WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION IS REQUIRED AND A CROWN WILL BE PLACED. RETAINER USAGE WAS NOT DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Tooth Fracture

  MAUDE report 15289003 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED LOSS OF TOOTH #10 WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION IS REQUIRED. RETAINER USAGE 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 15245876 ↗
• InjuryAug 16, 2022Adverse 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 A GUM SURGERY 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15238159 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED ROOT RESORPTION ON TEETH #8, #9 #24 AND #25 WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION IS REQUIRED. RETAINER USE WAS NOT 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 14843817 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Tooth Fracture

  MAUDE report 14746798 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT CROWN ON TOOTH #30 BROKE WHILE WEARING THE RETAINERS. MEDICAL INTERVENTION WAS REQUIRED AND THE CROWN WAS REPLACED. IT IS UNKNOWN IF RETAINER USAGE 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 14739088 ↗