MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-12 for INSIGNIA 3791506*1*1 manufactured by Ormco Corportation.
[5484150]
A doctor alleged that a patient had experienced the root of a lower incisor moving too far out and gum recession on that same tooth while receiving orthodontic treatment with the insignia clear product.
Patient Sequence No: 1, Text Type: D, B5
[13048805]
The doctor manually corrected the bracket to move the tooth back into alignment. It was reported that possible tissue regeneration surgery may be required to address the patient's gum recession; however, this information will not be known until the tooth is repositioned. An update will be provided if any new information becomes available. The product involved in the alleged incident was not returned. Due to the customized manufacturing of this product, no evaluation can be conducted without returned product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2015-00013 |
| MDR Report Key | 4596614 |
| Report Source | 07 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-02-03 |
| Date Mfgr Received | 2015-02-03 |
| Date Added to Maude | 2015-03-13 |
| 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 |
| 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 | 2015-03-12 |
| Catalog Number | 3791506*1*1 |
| Lot Number | 37915 |
| Operator | OTHER |
| 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 | 2015-03-12 |