MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-21 for INVISALIGN SYSTEM manufactured by Align Technology.
[307662]
While using an aligner (clear plastic tray designed to move teeth to correct malocclusion) pt's dental crown fractured. Pt was mid treatment (12 of 37) when the crown fractured at the cej (gingival line) on lower lateral incisor. After the fracture inciident, a post/core was placed, crown placed, and a new impression taken for continuation of invisalign treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2003-00001 |
| MDR Report Key | 441832 |
| Date Received | 2003-01-21 |
| Date of Report | 2003-01-16 |
| Date of Event | 2002-12-02 |
| Date Mfgr Received | 2002-12-02 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2003-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANAR KOTADIA |
| Manufacturer Street | 851 MARTIN AVE |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal | 95050 |
| Manufacturer Phone | 4084701455 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ORTHODONTIC APPLIANCE |
| Product Code | KMY |
| Date Received | 2003-01-21 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 430807 |
| Manufacturer | ALIGN TECHNOLOGY |
| Manufacturer Address | 851 MARTIN AVE SANTA CLARA CA 95050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-01-21 |