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.". NO ROOT CAUSE PROVIDED. ALIGN'S CLINICAL REVIEW OF AVAILABLE RECORDS SHOWS TOOTH #18 EXHIBITED A DISLODGED AMALGAM RESTORATION WITH PARTIAL LOSS OF MATERIAL, WHICH SIGNIFICANTLY COMPROMISED THE TOOTH'S STRUCTURAL INTEGRITY AND ITS ABILITY TO WITHSTAND OCCLUSAL FORCES. THIS CONCERN IS AMPLIFIED BY THE FACT THAT TOOTH #18 WAS THE ONLY REMAINING MOLAR IN THE LEFT QUADRANT, MAKING IT A CRITICAL COMPONENT FOR MASTICATION AND OCCLUSAL STABILITY. THE FAILURE OF THE AMALGAM RESTORATION LIKELY INCREASED SUSCEPTIBILITY TO SECONDARY CARIES, FRACTURE, AND PROGRESSIVE DETERIORATION, GIVEN THAT AMALGAM CAVITY PREPARATION INHERENTLY REMOVES HEALTHY TOOTH STRUCTURE AND REDUCES NATURAL SUPPORT. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE TOOTH LOSS (PERMANENT DAMAGE) AND THE INVISALIGN SYSTEM ALIGNERS 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 REPORTED THAT THE PATIENT REQUIRED EXTRACTION OF TOOTH #18. NO AVAILABLE INFORMATION AT THIS TIME.