MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for CLEAR ALIGNERS manufactured by Smile Direct Club / Align Technology, Inc..
[180122565]
I started smile direct club clear aligners in (b)(6) of 2019 and the overall process seemed to go well in terms of straightening my teeth. Then after 6 months of wearing the aligners, i began to have headaches and i am not able to chew with my back teeth like before i started the aligners. My back teeth do not properly line up and i have to chew with my front teeth. My bite is horrible now and i have to have a minimum of multiple thousands of dollars in braces and other corrective measures done to my teeth in order to fix my bite. I am still paying for smile direct club's aligners and cannot afford both braces and aligners at the same time. Nor can i afford the thousands of dollars it will cost to fix this issue. Images of before the aligners and after are to follow within the week. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093006 |
| MDR Report Key | 9711483 |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-05-24 |
| Date Added to Maude | 2020-02-14 |
| 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 | 3 |
| Brand Name | CLEAR ALIGNERS |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-02-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-13 |