MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for SMILE DIRECT CLUB ALIGNERS manufactured by Smile Direct Club / Align Technology, Inc..
[174882100]
Pt had initiated at-home dental aligners for correcting crowding and tooth rotations with smile direct club. Pt has 7 teeth with cavities and a retained primary tooth which is hyper-mobile with minimal root structure. Both issues should have been addressed prior to pt being approved for aligners. The primary tooth would likely have been extracted iatrogenically by the aligners. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092187 |
| MDR Report Key | 9581275 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-27 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| 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 CLUB ALIGNERS |
| Generic Name | ALIGNERS, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-01-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-10 |