MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2015-06-17 for INSIGNIA 3571801*1*1*1 manufactured by Ormco Corporation.
[5812018]
A doctor alleged that approximately three (3) weeks after placing the 19x25 tma wire into a patient's customized insignia brackets, the root of the ll1 tooth went through the bone.
Patient Sequence No: 1, Text Type: D, B5
[13356028]
Specific patient information with regard to age and weight was not provided. A doctor alleged that approximately three (3) weeks after placing the 19x25 tma wire into a patient's customized insignia brackets, the root of the ll1 tooth went through the bone. The patient returned to the office where the doctor performed a gum graft and manually corrected the tooth movement by flipping the insignia bracket to express positive torque. Patient has fully recovered and is doing fine at this time. 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 | 2016150-2015-00018 |
| MDR Report Key | 4851832 |
| Report Source | 00,07 |
| Date Received | 2015-06-17 |
| Date of Report | 2015-05-11 |
| Date Mfgr Received | 2015-05-11 |
| Date Added to Maude | 2015-06-18 |
| 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 | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 S. LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| 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 | 2015-06-17 |
| Catalog Number | 3571801*1*1*1 |
| Lot Number | 30039 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| 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 | 2015-06-17 |