INVISALIGN 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 POTENTIAL ROOT CAUSE OF THIS EVENT IS UNKNOWN; HOWEVER, THE TREATING DOCTOR INDICATED THAT OCCLUSION CHANGES DURING TREATMENT MAY HAVE CONTRIBUTED TO THE EVENT. ALIGN'S CLINICAL REVIEW OF AVAILABLE RECORDS INDICATES THAT TOOTH #5 WAS NOTED TO HAVE A DENTAL CROWN WITH VISIBLE SIGNS OF WEAR. THE PATIENT UNDERWENT TWO ALIGNER TREATMENT PHASES: THE FIRST CONSISTING OF 12 UPPER ALIGNERS, AND THE SECOND OF 4. NO SIGNIFICANT TOOTH MOVEMENTS WERE PROGRAMMED FOR TOOTH #5 THROUGHOUT THE COURSE OF TREATMENT. SCIENTIFIC LITERATURE CONSISTENTLY INDICATES THAT TEETH WITH BOTH A ROOT CANAL AND A CROWN ARE STRUCTURALLY COMPROMISED, WHICH PLACES THEIR LONG-TERM PROGNOSIS AT RISK. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN RETAINER CAUSED OR CONTRIBUTED TO THE REPORTED TOOTH FRACTURE AND SUBSEQUENT BRIDGE PLACEMENT EXTRACTION (PERMANENT DAMAGE), THEREFORE, AN MDR WILL BE 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 HAD SYMPTOMS OF TOOTH FRACTURE REQUIRING EXTRACTION AND BRIDGE PLACEMENT. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTION OR MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS BEYOND THE PRESCRIBED TYLENOL. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED.