N
Patient 1
THE DOCTOR RE-ATTACHED THE CHIPPED PORTIONS TO THE PATIENT'S TEETH USING A DENTAL ADHESIVE. THE SUSPECT DEVICE WAS OVER 10 YEARS OLD - WHICH IS 5 YEARS BEYOND THE STATED USE-LIFE OF THE PRODUCT.
MAUDE MDR 822758
- MDR report key
- 822758
- Report number
- 2016150-2007-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-11-01
- Date received
- 2007-03-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WENDY URTEL
- Address
- 1717 WEST COLLINS AVENUE ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCH BENDING PLIER | ORTHODONTIC PLIER | ORMCO CORP. | JEX | * | 803-0403 | * | N | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-03-01 | 0 | 1. R; 2. S |
Event Narratives#
D
Patient 1
IN JANUARY 2007 AN ATTORNEY INFORMED ORMCO CORPORATION THAT AN ARCH BENDING PLIER BROKE DURING AN ORTHODONTIC ADJUSTMENT PERFORMED BY HIS CLIENT/DOCTOR, CAUSING THE DOCTOR TO CHIP TWO OF THE PATIENT'S TEETH (#'S 9 & 10).