FDA Adverse Event Injury Summary report: N

SMILE DIRECT CLEAR

MDR report key: 9214104 · Received October 18, 2019

Report

Report Number
MW5090505
Event Type
Injury
Date Received
October 18, 2019
Date of Event
May 1, 2019
Report Date
October 17, 2019
Manufacturer
SMILE DIRECT / ALIGN TECHNOLOGY, INC.
Product Code
NXC
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

WHEN I SIGNED UP FOR SMILE DIRECT I WAS REQUIRED TO DO A PRESCREENING. ON THE FORM, A SPECIFIC QUESTION I STUMBLED OVER, BUT DID NOT INQUIRE ABOUT BECAUSE I THOUGHT A PROFESSIONAL WOULD FURTHER ASK IF NEEDED TO INSURE ME SAFETY WISE. DO YOU HAVE ANY UNTREATED PERIODONTAL ISSUES? SINCE I DO GO TO MY PERI CLEANINGS MOST OF THE TIME I CHECKED THE NO BOX. AND THAT WAS THAT. HALFWAY THROUGH MY 6 MONTH TREATMENT, I WENT TO MY GENERAL DENTIST TO HAVE A CLEANING. AT THE END OF IT I ADMITTED TO USING SMILE DIRECT. I DID NOT HAVE MUCH INFO ON THIS COMPANY AND WAS SLIGHTLY EMBARRASSED TO HAVE USED A SMALL ORDER ORTHODONTIST, AND BY THE WAY MY DENTIST WAS LOOKING AT ME. I KNEW I WASN'T ABOUT TO HEAR GOOD NEWS. I TOLD HIM I FIGURED IT HAD TO BE SAFE BECAUSE A WHOLE COMPANY WOULDN'T JUST LET PEOPLE'S TEETH FALL OUT OR BE COMPROMISED, RIGHT? WRONG. MY DENTIST CORRECTLY INFORMED ME ABOUT THE DANGERS OF MOVING YOUR TEETH TOO FAST AND POSSIBLE ROOT RESORPTION AND THAT MY TEETH COULD FALL OUT IF I CONTINUED TREATMENT. PRETTY SURE THAT'S THE EXACT OPPOSITE OF WHAT I WAS INTENDING TO HAVE DONE. I CONTINUED TO WEAR MY MOST CURRENT ALIGNERS TO STABILIZE MY TEETH UNTIL I WENT AND SAW AN ORTHODONTIST PER MY DENTIST ORDERS. AFTER HAVING TO PAY FOR APPROPRIATE ORTHODONTIC SERVICES, INCLUDING A FULL PANORAMIC X-RAYS AND A HIGHER QUALITY RETAINER TO HELP STABILIZE MY TEETH. I AM CURRENTLY BEING MONITORED BY SAID ORTHODONTIST, TO MAKE SURE THERE'S NO LINGERING DAMAGE. WORKING WITH MY GENERAL DENTIST AND ORTHODONTIST, SOMETHING CRITICAL FOR PTS LIKE ME. I MAY BE ABLE TO CONTINUE PROFESSIONAL ORTHODONTIC SERVICES IN THE FUTURE. I FELT DUPED. SMILE DIRECT WAS VERY WILLING TO FULLY REIMBURSE ME HOWEVER, TO KEEP ME QUIET, I'M NOT A QUIET PERSON. BOTH TIMES I WENT INTO A (B)(6), I WAS RECORDED IN ORDER TO GET A FREE RETAINER, WHICH I NEVER DID GET IT AND I HAD TO PAY FOR IN THE LONG RUN TO STABILIZE MY TEETH. IF YOU NEED FURTHER INFO I WOULD BE HAPPY TO ASSIST. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1000451 SMILE DIRECT CLEAR ALIGNERS ALIGNER, SEQUENTIAL NXC SMILE DIRECT / ALIGN TECHNOLOGY, INC.

Patients

Seq Age Sex Outcome Treatment
1 37 YR Required Intervention