MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for SMILE DIRECT CLUB CLEAR ALIGNERS manufactured by Smiledirectclub Llc.
[129186753]
I was using smile direct club clear aligners for over a year. Every 6 months you are supposed to change your retainers. I started using a new retainer on (b)(6) 2018. The retainer seemed like it was not made properly the first night i put it in, it did not fit my teeth properly. I first assumed i needed time to adjust. After a week or so i noticed my teeth hurt more, my jaw hurt, and i was having ear pain and ringing. When i went to my dentist they said the aligners had thrown off my bite, and created tmj / tmd symptoms. I have since stopped all use of smile direct club aligners, and started using a nightly dental splint/guard made by my dentist to correct the issues that smile direct club created.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081753 |
| MDR Report Key | 8119825 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-08-30 |
| Date Added to Maude | 2018-11-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SMILE DIRECT CLUB CLEAR ALIGNERS |
| Generic Name | POSITIONER TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2018-11-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMILEDIRECTCLUB LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-29 |