D
Patient 1
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.
MAUDE MDR 4851832
- MDR report key
- 4851832
- Report number
- 2016150-2015-00018
- Event key
- 0
- Event type
- 3
- Date received
- 2015-06-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. SUZETTE RAMPAIR-JOHNSON
- Address
- 1332 S. LONE HILL AVE. GLENDORA CA 91740 US
- Phone
- 909-909-9099
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | ORTHODONTIC PLASTIC BRACKET | ORMCO CORPORATION | DYW | 3571801*1*1*1 | 30039 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-17 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
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.