FDA Adverse Event Injury Summary report: N

INVISALIGN

MDR report key: 1040316 · Received May 8, 2008

Report

Report Number
MW5006767
Event Type
Injury
Date Received
May 8, 2008
Date of Event
February 22, 2008
Report Date
May 8, 2008
Manufacturer
ALIGN TECHNOLOGY, INC.
Product Code
NXC
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MY DENTIST PRESCRIBED INVISALIGN BRACES TO CORRECT MY BITE PROBLEMS. I WORE THE BRACES AS DIRECTED AND FOUND THAT THEY OFTEN BURNED MY GUMS. I SOLDIERED THROUGH BUT FOUND THE BURNING FROM THE RETAINERS TO BE UNBEARABLE. MY DENTIST SHORTENED THEM, BUT I COULD NOT WEAR THEM AT NIGHT FOR FEAR OF SWALLOWING THEM AS THE SHORTENED ONES SHOULD FALL OUT OF MY MOUTH, ESPECIALLY WHEN I SNEEZED. THE BURNING CONTINUES AND CONTINUED. WHEN I READ AN ARTICLE ABOUT THE USE OF PHTHALATES IN PLASTICS I BECAME CONCERNED BECAUSE I KNEW I WAS ALLERGIC TO THOSE CHEMICALS WHEN USED TO STABILIZE FRAGRANCES. I CALLED THE COMPANY TO ASK IF THEY USED PHTHALATES IN THE PLASTIC FOR INVISALIGN AND THEY SAID THEY WOULD ONLY SPEAK TO MY DENTIST. MY DENTIST CALLED AND THEY FAXED HIM A QUESTIONNAIRE FOR ME TO FILL OUT, WHICH I DID - THAT IS THE DATE I USED ON THIS FORM, ALTHOUGH THE PROBLEM WAS OCCURRING LONG BEFORE THAT. HE FORWARDED MY ANSWERS BUT SAID THEY REFUSED TO ANSWER THE DIRECT QUESTION AS TO WHETHER OR NOT PHTHALATES WERE USED IN THE MANUFACTURE OF THE PLASTIC FOR THEIR PRODUCT. IN ADDITION TO THE BURNING PROBLEM, THE BOTTOM RETAINERS EVENTUALLY SPLIT ALMOST IN HALF. SEVERAL TIMES DURING THE COURSE OF TREATMENT, THE BOTTOM BRACES TORE BEFORE THE PRESCRIBED ROTATION WAS UP. I CALLED AND COMPLAINED TO THE COMPANY ABOUT THAT AND THEY REFUSED TO SPEAK TO ME AND REFERRED ME TO MY DENTIST WHO DID NOTHING ABOUT IT. I ASKED FOR THE OLD FASHIONED WIRES RETAINERS INSTEAD. AND, BECAUSE OF THE UNRESOLVED BURNING AND SWELLING, I HAD THAT DONE ON THE UPPER TEETH. MY LIPS ARE STILL SWOLLEN AND OCCASIONALLY BURN. I WENT TO A DERMATOLOGIST WHO EXPLAINED IT WILL TAKE A LONG TIME TO RETURN TO NORMAL. I FEEL BETRAYED AND FRUSTRATED THAT THE COMPANY WILL NOT RESPOND TO MY CONCERNS, ESPECIALLY NOW WITH THE RISKS WITH PHTHALATES AND PLASTIC WATER BOTTLES! CAN YOU PLEASE HELP ME FIND OUT ABOUT THIS? DATES OF USE: 2007- 2008. DIAGNOSIS OR REASON FOR USE: PROBLEMS WITH BITE. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INVISALIGN INVISALIGN NXC ALIGN TECHNOLOGY, INC. PTID 847226

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other