MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for SMILE DIRECT CLUB manufactured by Smile Direct Club / Align Technology Inc..
[183738391]
Pt is using smile direct club. Pt is almost done with treatment (only three trays left). If the case was overseen by an orthodontist, the number of trays she has left would mean her teeth were about in the correct position and only a few minor changes to go. Pt however still has crowded, overlapping lower lateral incisors and canines. Pt has a 2mm midline discrepancy. Pt has numerous flared maxillary teeth, rotated teeth, and both arches have teeth that are not in the correct arch form. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093749 |
| MDR Report Key | 9834731 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-11 |
| Date Added to Maude | 2020-03-16 |
| 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 | 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 |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-03-13 |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-13 |