VIVERA RETAINER

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 TOOTH PROGNOSIS WAS GOOD. THE TOOTH WAS NOT EXPECTED TO BE EXTRACTED OR LOST DURING TREATMENT. TREATING DOCTOR DOESN'T KNOW IF TREATMENT PLAN COULD HAVE AGGRAVATED THE CLINICAL CONDITION. ALIGN'S CLINICAL REVIEW NOTED THAT THE PATIENT UNDERWENT TWO ROUNDS OF ALIGNER THERAPY, WITH THE FIRST CONSISTING OF 15 UPPER AND 18 LOWER ALIGNERS AND THE SECOND CONSISTING OF 18 ALIGNERS. THE INITIAL TREATMENT PLAN DEMONSTRATED UNEVEN OCCLUSAL CONTACTS PRIOR TO TREATMENT, INCLUDING HEAVIER CONTACT ON TOOTH #5. FOLLOWING THE FIRST ROUND, OCCLUSAL CONTACTS WERE REDISTRIBUTED, WITH REDUCED CONTACT ON TOOTH #5. THE FINAL PROGRAMMED OCCLUSION SHOWED GENERALLY EVEN CONTACTS POSTERIORLY, WITH THE EXCEPTION OF TEETH LACKING ANTAGONISTS. TOOTH #5 DID NOT UNDERGO MODERATE OR COMPLEX MOVEMENTS DURING TREATMENT. THE PATIENT INITIALLY PRESENTED WITH A POSTERIOR OPEN BITE, WHICH TREATMENT AIMED TO CORRECT. THE MOST RECENT RECORD SHOWING THE TOOTH PRESENT AND REPORTEDLY HEALTHY WAS DATED (B)(6) 2025. NO RADIOGRAPHIC RECORDS WERE AVAILABLE TO FURTHER ASSESS THE CONDITION OF THE TOOTH. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE VIVERA RETAINER CAUSED OR CONTRIBUTED TO THE REPORTED PERMANENT DAMAGE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD PERMANENT DAMAGE, AND THE VIVERA RETAINER WERE BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803. THE EXACT DATE OF THE EVENT IS UNKNOWN. DESPITE REASONABLE EFFORTS, NO CONCLUSIVE INFORMATION WAS AVAILABLE TO DETERMINE WHEN THE EVENT OCCURRED. THE DATE (B3) PROVIDED CORRESPONDS TO THE DATE THE EVENT WAS REPORTED TO THE MANUFACTURER AND DOES NOT NECESSARILY REFLECT THE ACTUAL DATE OF OCCURRENCE.

Description of Event or 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.