SNAPLINK BUCCAL TUBE

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 SECOND 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 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.