InjuryDYW
INSIGNIA
Received Jan 28, 2015
Report 2016150-2015-00003 · MDR key 4460816
Device
Generic name
Orthodontic Plastic Bracket
Manufacturer
Ormco CorportationCatalog number
3787674*1*1
Lot number
53675
Product problems
- Loose or Intermittent Connection
- Failure to Osseointegrate
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
INFORMATION WITH REGARD TO PATIENT AGE AND WEIGHT WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO THE DOCTOR'S OFFICE ON (B)(6) 2015 TO OBTAIN FURTHER INFORMATION; HOWEVER, THE DOCTOR'S OFFICE HAS REMAINED UNRESPONSIVE. THE PRODUCT WAS NOT RETURNED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.
Description of Event or Problem
A DOCTOR ALLEGED THAT TOOTH #11 AND TOOTH #23 FELT LIKE THEY WERE OUT OF THE CORTICAL BONE AFTER PLACEMENT OF INSIGNIA FOR A PATIENT.
Additional Manufacturer Narrative
.