SNAPLINK BUCCAL TUBE
Received Aug 19, 2013
Report 2016150-2013-00099 · MDR key 3296301
Device
Generic name
Orthodontic Tube
Manufacturer
Ormco CorporationProduct problems
- Break
- Difficult to Open or Close
Patient
18 YR
- Deformity/ Disfigurement
Narrative
Description of Event or Problem
A DOCTOR HAD ALLEGED THAT THE DOORS OF THE SNAPLINK BUCCAL TUBES WOULD NOT STAY CLOSED OR HAD BROKEN OFF, CAUSING THE MOLARS TO ROTATE ONE (1) PATIENT.
Additional Manufacturer Narrative
THE DOCTOR HAD IDENTIFIED TWO (2) SNAPLINK BUCCAL TUBES WHICH WERE 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 TUBES, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEVICES INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.