VIVERA RETAINERS
Received May 28, 2025 · Event occurred May 15, 2025
Report 2953749-2025-01231 · MDR key 22097517
Device
Generic name
Maintainer, Space Preformed, Orthodontic
Manufacturer
Align Technology, Inc.Model number
8579Lot number
183495805
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR · Female
- Tooth Loss
- Tooth Loss
Narrative
Description of Event or 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.
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.". THE TREATING DOCTOR SHARED THAT THE PRE-EXISTING CLINICAL CONDITION WAS THE MAIN FACTOR FOR TOOTH/TEETH TO BE EXTRACTED, HOWEVER, DOESN'T KNOW IF TREATMENT PLAN COULD HAVE AGGRAVATED THE CLINICAL CONDITION. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE REQUIRED A TOOTH EXTRACTION (PERMANENT DAMAGE) AND THE INVISALIGN SYSTEM ALIGNERS WERE BEING USED. THEREFORE, AN MDR IS BEING FILED IN THE UNITED STATES PER 21 CFR 803.