ACCESS DENTAL LAB 100-0362Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00850007728113), received between Jul 22, 2021 and Nov 15, 2023 — classified as 49 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE, 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 18137357 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DAMAGED DENTAL WORK ON BACK MOLAR TOOTH #30 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17652103 ↗
• InjuryAug 18, 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 #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND TOOTH #8 WILL NEED A ROOT CANAL AND A VENEER. 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 17577711 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DAMAGE ON FRONT RIGHT INCISOR WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL WAS 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 17390904 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TEETH #4 AND #5 BROKE WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND ROOT CANALS WERE 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 16963488 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NECROSIS ON TOOTH #30 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 16838571 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #30 CRACKED WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND THE TOOTH WAS EXTRACTED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS C376F9E119120C AND THE COMPLAINT NUMBER IS ID-347314.

  Patient problems: Tooth Fracture

  MAUDE report 16587889 ↗
• InjuryFeb 24, 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 ID-(B)(4).

  Patient problems: Necrosis

  MAUDE report 16439867 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED MOBILITY ON TOOTH #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A BONE GRAFT WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS ID: (B)(4).

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

  MAUDE report 16356967 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CHIPPED TOOTH ON #18 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL AND A CROWN WERE 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 16174449 ↗
• InjuryJan 6, 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, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. 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 16116511 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN TOOTH ON #19 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED AND A ROOT CANAL AND A CROWN NEED TO 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 15847689 ↗
• InjuryNov 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #5 BROKE WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED. ALIGNER 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 15829666 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A NERVE DAMAGE WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL WILL 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 15784074 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER MEDICAL INTERVENTION WAS REQUIRED, AND A ROOT CANAL WAS 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 15568130 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A ROOT RESORPTION ON #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED AND AN EXTRACTION NEEDS TO BE PERFORMED AND IMPLANTS NEEDS TO BE PLACED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15542981 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CRACKED CROWN ON #3 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15414579 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN BRIDGE ON #18 #19 AND #20 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED AND IMPLANTS WILL BE PLACED. 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 15414576 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CROWN THAT CAME OUT WITH THE TOOTH INSIDE OF IT ON #12 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AN EXTRACTION WAS PERFORMED AND A BRIDGE WILL BE PLACED. 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 15365880 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON TOOTH #9. 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 15342306 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED LOSS OF TOOTH #24 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, THE TOOTH WAS EXTRACTED, A BONE GRAFT WAS PERFORMED AND AN IMPLANT WILL BE PLACED. 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 15342215 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A TOOTH FRACTURE ON #8 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED AND EVENTUALLY IT WILL RESULT IN COMPLETE LOSS OF THE TOOTH. 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 15341172 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THREE CRACKED CROWNS WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TEETH NUMBER. MEDICAL INTERVENTION IS REQUIRED AND NEW CROWNS WILL BE PLACED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15244259 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CRACKED CROWN ON #9 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15237033 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT CROWNED TOOTH #9 BROKE WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, THE TOOTH WAS EXTRACTED AND AN IMPLANT WAS PLACED. 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 15172144 ↗