MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for SMILE DIRECT ALIGNERS manufactured by Align Technology, Inc..
[177586471]
I used smile direct club aligners for orthodontic treatment. The end result is that i need expensive corrective treatment to fix the misalignment of all my back teeth. They are twisted and tilted and i can no longer chew properly. I spent thousands of dollars on smile direct because i was self conscious of my smile and the company offered a solution that was cheaper than other options. My dentist is fearful that i will have serious issues for the rest of my life because my jaw and teeth are no longer aligned properly. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092681 |
| MDR Report Key | 9659200 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-29 |
| Date Added to Maude | 2020-02-03 |
| 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 | SMILE DIRECT ALIGNERS |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-01-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |