INSIGNIA
Received Jun 17, 2015
Report 2016150-2015-00018 · MDR key 4851832
Device
Generic name
Orthodontic Plastic Bracket
Manufacturer
Ormco CorporationCatalog number
3571801*1*1*1
Lot number
30039
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Tissue Damage
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED. A DOCTOR ALLEGED THAT APPROXIMATELY THREE (3) WEEKS AFTER PLACING THE 19X25 TMA WIRE INTO A PATIENT'S CUSTOMIZED INSIGNIA BRACKETS, THE ROOT OF THE LL1 TOOTH WENT THROUGH THE BONE. THE PATIENT RETURNED TO THE OFFICE WHERE THE DOCTOR PERFORMED A GUM GRAFT AND MANUALLY CORRECTED THE TOOTH MOVEMENT BY FLIPPING THE INSIGNIA BRACKET TO EXPRESS POSITIVE TORQUE. PATIENT HAS FULLY RECOVERED AND IS DOING FINE AT THIS TIME. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. DUE TO THE CUSTOMIZED MANUFACTURING OF THIS PRODUCT, NO EVALUATION CAN BE CONDUCTED WITHOUT RETURNED PRODUCT.
Description of Event or Problem
A DOCTOR ALLEGED THAT APPROXIMATELY THREE (3) WEEKS AFTER PLACING THE 19X25 TMA WIRE INTO A PATIENT'S CUSTOMIZED INSIGNIA BRACKETS, THE ROOT OF THE LL1 TOOTH WENT THROUGH THE BONE.