INSIGNIA
Received Jun 24, 2015
Report 2016150-2015-00019 · MDR key 4865176
Device
Generic name
Orthodontic Plastic Bracket
Manufacturer
Ormco CorporationCatalog number
3919598*1*1
Lot number
75940
Product problems
- Fitting Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT THE INSIGNIA JIG DID NOT FIT; THEREFORE, HE REMOVED THE BRACKETS FROM THE JIG AND PLACED THEM MANUALLY.
Additional Manufacturer Narrative
SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED. A DOCTOR ALLEGED THAT THE INSIGNIA JIG DID NOT FIT; THEREFORE HE REMOVED THE BRACKETS FROM THE JIG AND PLACED THEM MANUALLY. THE PATIENT WILL RETURN FOR REMOVAL OF THE BRACKETS AND A NEW INSIGNIA KIT WILL BE CREATED AND PLACED. THE DEVICE WAS RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.