MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-04-07 for INSIGNIA 3425966*1*1 manufactured by Ormco Corportation.
[4323800]
A doctor alleged that two (2) patient had experienced unexpected teeth movement after placement with insignia single patient kit. This is the first of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[11764974]
The doctor placed a temporary anchorage device for the patient to correct the movement. To date, the patient is doing fine. The product alleged in this incident was not returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00024 |
| MDR Report Key | 3728707 |
| Report Source | * |
| Date Received | 2014-04-07 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-03-25 |
| Date Added to Maude | 2014-04-07 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSIGNIA |
| Generic Name | ORTHODONTIC PLASTIC BRACKET |
| Product Code | DYW |
| Date Received | 2014-04-07 |
| Catalog Number | 3425966*1*1 |
| Lot Number | 19034 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORTATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-04-07 |