D
Patient 1
A DOCTOR ALLEGED THAT APPROXIMATELY TWENTY (20) PATIENTS HAD EXPERIENCED THE ROTATION OF A LOWER FIRST MOLAR AFTER THE DOORS OF THE SNAPLINK BUCCAL TUBES HAD BROKEN. THIS IS THE NINETEENTH OF TWENTY (20) REPORTS.
MAUDE MDR 3287446
- MDR report key
- 3287446
- Report number
- 2016150-2013-00095
- Event key
- 0
- Event type
- 3
- Date received
- 2013-08-14
- 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. KERRI CASINO
- 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 | SNAPLINK BUCCAL TUBE | ORTHODONTIC TUBE | ORMCO CORPORATION | DZD | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-14 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. ALTHOUGH THE DOCTOR IDENTIFIED TWO DIFFERENT SNAPLINK CATALOG NUMBERS ASSOCIATED WITH THE ROTATION OF THE PATIENT'S MOLAR, HE COULD NOT VERIFY WHICH CATALOG NUMBER WAS USED ON THE PATIENT; THEREFORE, NO CATALOG NUMBERS WERE IDENTIFIED IN THIS REPORT. THE CATALOG NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDE 438-2191 AND 438-2190. THE DOCTOR REPLACED THE PATIENT'S BUCCAL TUBE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.