VIVERA RETAINERS
Received May 21, 2025 · Event occurred May 1, 2025
Report 2953749-2025-01085 · MDR key 22060605
Device
Generic name
Maintainer, Space Preformed, Orthodontic
Manufacturer
Align Technology, Inc.Model number
8579Lot number
159959819
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
65 YR · Female
- Tooth Loss
- Tooth Loss
Narrative
Additional Manufacturer Narrative
THE CURRENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: "PRECAUTIONS - A TOOTH THAT HAS BEEN PREVIOUSLY TRAUMATIZED OR SIGNIFICANTLY RESTORED MAY BE AGGRAVATED. IN RARE INSTANCES, THE USEFUL LIFE OF THE TOOTH MAY BE REDUCED, THE TOOTH MAY REQUIRE ADDITIONAL DENTAL TREATMENT SUCH AS ENDODONTIC AND/OR ADDITIONAL RESTORATIVE WORK, AND/OR THE TOOTH MAY BE LOST.". NO ROOT CAUSE WAS PROVIDED. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE VIVERA RETAINERS CAUSED OR CONTRIBUTED TO THE REQUIRED A TOOTH EXTRACTION (PERMANENT DAMAGE) AND THE VIVERA RETAINERS WERE BEING USED. THEREFORE, AN MDR IS BEING FILED IN THE UNITED STATES PER 21 CFR 803. THERE IS NO CONCLUSIVE EVIDENCE TO CONFIRM THE DATE OF THE REQUIRED TOOTH EXTRACTION, AND THE DATE (B3) IS BASED ON THE TIMELINES REPORTED TO ALIGN AND COMPARED TO PATIENT INFORMATION.
Description of Event or 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.