SNAPLINK BUCCAL TUBE
Received Aug 14, 2013
Report 2016150-2013-00080 · MDR key 3287332
Device
Generic name
Orthodontic Tube
Manufacturer
Ormco CorporationProduct problems
- Break
Patient
Not reported
- Deformity/ Disfigurement
Narrative
Description of Event or Problem
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 FOURTH OF TWENTY (20) REPORTS.
Additional Manufacturer Narrative
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.