Vivera Realine 8567Recalls & reported problems
Align Technology, Inc. · Retainer · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816063020172), received between Jan 18, 2024 and Jan 18, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF JAW PAIN DUE TO MOVEMENTS IN THE TEETH, WHICH HAS NOW RESULTED IN THE NEED FOR THE PATIENT TO UNDERGO JAW SURGERY TO FIX TMJ. THE PATIENT REPORTED BEING REFERRED TO A SPECIALIST BY THE TREATING DOCTOR HOWEVER WAS UNABLE TO AFFORD THIS AND THE PATIENT, INSTEAD, REPORTED VISITING A PCP TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT REPORTED BEING ADVISED BY THE TREATING DOCTOR TO TAKE MUSCLE RELAXERS (OTC) TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE RETAINERS.
Patient problems: Pain
MAUDE report 18536156 ↗
Other Maintainer, Space Preformed, Orthodontic devices
- Vivera 8579Align Technology, Inc. · Maintainer, Space Preformed, Orthodontic13 reports
- Invisalign 1011Align Technology, Inc. · Maintainer, Space Preformed, Orthodontic4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.