Vivera 8579Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00816063020110), received between Sep 14, 2022 and Jul 2, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS INVOLVING TOOTH #5. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION AS A RESULT OF THE EVENT. THE PATIENT INDICATED TAKING ANTIBIOTICS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING TREATMENT WITH THE VIVERA RETAINERS AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Tooth Loss

  MAUDE report 25693096 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF PAIN WHEN BITING ON TOOTH #19 AND AN ILL FITTING RETAINER OVER TOOTH #19. THE PATIENT'S AS TOOTH #18 WAS EXTRACTED. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED OR TOOK ANY MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT DISCONTINUED OR CONTINUED USE OF THE RETAINERS, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Pain; Tooth Loss

  MAUDE report 24240245 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED EXTRACTION OF TOOTH #18. NO AVAILABLE INFORMATION AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 23665985 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTS THE PATIENT HAD DEVELOPED A PERIAPICAL LESION AND THEN DECIDED TO EXTRACT TOOTH #19. BONE GRAFT WAS REQUIRED AND NOW SPACE IS READY FOR FUTURE IMPLANT. THE PATIENT DIDN'T STOP THE USE OF THE PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 22097517 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR IS REPORTING TOOTH LOSS (NO SPECIFIC TOOTH WAS MENTIONED). THE PATIENT DIDN'T NEED ANY FURTHER MEDICAL INTERVENTION. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED OR TOOK ANY MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOM.

  Patient problems: Tooth Loss

  MAUDE report 22060605 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR IS REPORTING THAT THE PATIENT'S TONGUE WAS INJURED AND THE LESION REQUIRED TO BE REMOVED VIA SURGERY. THE PATIENT REQUIRED MEDICAL INTERVENTION AND LAB/TEST WERE PERFORMED BUT COULD NOT TO BE PROVIDED. THE PATIENT WAS PRESCRIBED WITH MEDICATIONS BUT THEY ARE UNKNOWN. PATIENT STOPPED THE USE OF THE PRODUCT. WHEN ASKED HOW IS THE PATIENT DOING BY NOW TREATING DOCTOR SHARED THE FOLLOWING: AFTER SURGERY PATIENT'S IS GOOD.

  Patient problems: Localized Skin Lesion

  MAUDE report 21978457 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TEETH LOSS (#19 AND #31). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 21304066 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THERE WAS A TOOTH LOSS (NO SPECIFIC TOOTH WAS MENTIONED). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 21113327 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DIRECTLY TO ALIGN THE FOLLOWING SYMPTOMS: BITE ISSUES, TMJ, AND A MOLAR ON THE UPPER LEFT ARCH FELL OUT WHEN FLOSSING (OR A PIECE OF THE PATIENT'S TOOTH). THE PATIENT REQUIRED VISITING A SECOND DENTIST, WHO FILLED THE GAP SO THE TOOTH ROOT WAS NOT EXPOSED AND WHO DIAGNOSED THE PATIENT WITH TMJ. THE PATIENT REPORTED TAKING MUSCLE RELAXERS TO ALLEVIATE THE REPORTED SYMPTOMS.

  Patient problems: Pain; Tooth Fracture; Tooth Loss

  MAUDE report 20400900 ↗
• InjuryJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT DIRECTLY REPORTED TO ALIGN THE FOLLOWING SYMPTOMS: TOOTH PROTRUDING FROM GUM, TOOTH INFECTION, AND TOOTH EXTRACTION (3 PERMANENT TEETH) WITH A BRIDGE INSTALLED. THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE FOLLOWING SYMPTOMS: SEVERE DISTAL BONE LOSS AND MOBILITY ON TOOTH #23, LEADING TO EXTRACTION OF TOOTH #23. THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED THE FOLLOWING MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS: VISITING A PERIODONTIST, EXTRACTION OF TOOTH #23, AND A BRIDGE INSTALLED FROM TOOTH #22-24; AND THE PATIENT WAS PRESCRIBED AMOXICILLIN. THE TREATING DOCTOR REPORTED THAT THE PATIENT WAS DOING FINE, FROM THE LAST OFFICE VISIT A FEW YEARS AGO.

  Patient problems: Tooth Loss; Unspecified Infection

  MAUDE report 19644430 ↗
• InjuryMay 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT DIRECTLY REPORTED TO ALIGN THE FOLLOWING SYMPTOMS, WHICH THE TREATING DOCTOR CONFIRMED: SYMPTOMS OF A CROWN FALLING OFF OF A TOOTH ON THE UPPER RIGHT SIDE, TOOTH BECAME INFECTED AND REQUIRED EXTRACTION (UNSPECIFIED TOOTH #), AND A SECOND LOWER MOLAR REQUIRED EXTRACTION (UNSPECIFIED TOOTH #) WITH THE ANTERIOR TOOTH BEING CHIPPED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Fracture; Tooth Loss; Unspecified Infection

  MAUDE report 19383601 ↗
• InjuryFeb 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF SWOLLEN LIPS, BURNING SENSATION AND ANAPHYLACTIC EPISODE. THE PATIENT REPORTED REQUIRING VISITING THE EMERGENCY ROOM TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED PREDNISONE AND EPI-PEN BY THE EMERGENCY ROOM TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED DISCONTINUING THE USE OF THE RETAINERS ON (B)(6) 2023 AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Anaphylactic Shock; Burning Sensation; Swelling/ Edema

  MAUDE report 16358016 ↗
• InjurySep 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF TOOTH NECROSIS, ROOT RESORPTION AND EXTRACTION OF TOOTH #8. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE RETAINERS.

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

  MAUDE report 15422603 ↗