MIDCOURSE CORRECTIONS KIT 100-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00850007728014), received between Aug 24, 2021 and Aug 24, 2023 — classified as 43 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DAMAGE ON CROWN #7 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND A BRIDGE WAS 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 17613224 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A ROOT CANAL WHILE WEARING THE ALIGNERS.MEDICAL INTERVENTION WILL BE 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 17600732 ↗
• InjuryJun 14, 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 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 17131462 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN TOOTH ON #7 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 16924061 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A LOWER POSTERIOR TOOTH CRACKED WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION IS REQUIRED, AND A ROOT CANAL OR AN EXTRACTION 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: Tooth Fracture

  MAUDE report 16861625 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON A FRONT TOOTH 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 DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 16820352 ↗
• InjuryMar 10, 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 NOT DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS (B)(6) AND THE COMPLAINT NUMBER IS (B)(4).

  Patient problems: Necrosis

  MAUDE report 16525834 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #17 CRACKED WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND THE TOOTH WAS EXTRACTED. 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: Tooth Fracture

  MAUDE report 16474157 ↗
• 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 #14 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 16273909 ↗
• InjuryNov 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A BROKEN CROWN ON TOOTH #5 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AND AN IMPLANT WILL BE PLACED. 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 15829675 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #10 BROKE WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED, AND AN EXTRACTION WAS PERFORMED. ALIGNER TREATMENT WAS DISCONTINUED. FOR THIS EVENT, THE PATIENT IDENTIFIER IS C3D010CFE59C89 AND THE COMPLAINT NUMBER IS ID-(B)(4)..

  Patient problems: Tooth Fracture

  MAUDE report 15663465 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON #7 AND #27 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED, AMD ROOT CANALS 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: Necrosis

  MAUDE report 15653228 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE ON UPPER ANTERIOR TOOTH 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 15611098 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN INFECTION 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: Wound Infection

  MAUDE report 15523188 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A TOOTH LOSS ON #19 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND AN EXTRACTION OF THE ROOT WAS PERFOMED 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 15522612 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NECROSIS ON LOWER TEETH. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TEETH NUMBERS. MEDICAL INTERVENTION IS REQUIRED AND AN ENDODONTIC TREATMENT 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 15396486 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED MOBILITY ON TOOTH #24. MEDICAL INTERVENTION WAS REQUIRED AND A GUM GRAFT 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 15374520 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #18 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 15342301 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TOOTH MOBILITY ON TOOTH #7 AND #8. 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 15342156 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED NERVE DAMAGE TO ONE OF THE BOTTOM TEETH WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. IT IS UNKNOWN IF 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: Necrosis

  MAUDE report 15342105 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A DISLODGED CROWN ON TOOTH #5 WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION IS REQUIRED AND A NEW CROWN 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 15307002 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A DISLODGED BRIDGE AND BROKEN TOOTH ON LOWER RIGHT. MEDICAL INTERVENTION IS REQUIRED, THE BRIDGE WAS RECEMENTED AND AN IMPLANT WILL BE PLACED. ALIGNER TREATMENT WAS DISCONTINUE. 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 15288975 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT TOOTH #19 BROKE 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 Fracture

  MAUDE report 15245879 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A DISLODGED CROWN AND AN INFECTION WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED AND A EXTRACTION ON #5 AND A ROOT CANAL ON #12 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; Wound Infection

  MAUDE report 15158590 ↗
• InjuryJul 26, 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 ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. MEDICAL INTERVENTION IS REQUIRED AND AN IMPLANT 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 15107708 ↗