ORTHO SOLO
Received Aug 10, 2004 · Event occurred Jan 1, 2004
Report 2016150-2004-00004 · MDR key 5547801
Device
Generic name
Sealer And Bond Enhancer
Manufacturer
Ormco Corp.Model number
NACatalog number
740-0269
Lot number
UNK
Product problems
- Fracture
Patient
UNK
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
IN A F/U CONVERSATION WITH THE ORTHODONTIST, THE USE OF ORTHO SOLO COULD NOT BE CONFIRMED IN ANY OF THE 6 INSTANCES. INITIALLY, THE ORTHODONTIST THOUGHT ORTHO SOLO WAS USED, BUT SINCE NO RECORDS WERE RETAINED TO CONFIRM THAT FACT, THE ORTHODONTIST WAS NOT 100% SURE ORTHO SOLO WAS INVOLVED. THE ORTHODONTIST DID NOT PROVIDE ANY LOT NUMBERS OF PRODUCTS ALLEGEDLY INVOLVED NOR DID HE RETURN ANY SUSPECTED PRODUCTS FOR EVALUATION.
Description of Event or Problem
BETWEEN (B)(6) 2004, SIX INSTANCES (6 DIFFERENT PATIENTS) OCCURRED IN WHICH THE USE OF ORTHO SOLO, A SEALANT AND BOND ENHANCER, ALLEGEDLY ATTRIBUTED TO ENAMEL FRACTURES WHILE DEBONDING ORTHODONTIC BRACKETS. ALL OF THE PATIENTS WERE REFERRED TO THEIR GENERAL DENTISTS TO ASSESS THEIR CONDITIONS. THREE OF SIX PATIENTS REQUIRED COMPOSITE RESTORATIONS TO REPAIR THE ENAMEL FRACTURES. THIS IS THE THIRD OF THREE MDR'S REGARDING THE ALLEGED ASSOCIATION BETWEEN ORTHO SOLO AND THE ENAMEL FRACTURES THAT OCCURRED BETWEEN (B)(6) 2004.