InjuryDYW
INSIGNIA
Received Apr 7, 2014
Report 2016150-2014-00024 · MDR key 3728707
Device
Generic name
Orthodontic Plastic Bracket
Manufacturer
Ormco CorportationCatalog number
3425966*1*1
Lot number
19034
Product problems
- Migration or Expulsion of Device
Patient
41
- No Code Available
Narrative
Additional Manufacturer Narrative
THE DOCTOR PLACED A TEMPORARY ANCHORAGE DEVICE FOR THE PATIENT TO CORRECT THE MOVEMENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem
A DOCTOR ALLEGED THAT TWO (2) PATIENT HAD EXPERIENCED UNEXPECTED TEETH MOVEMENT AFTER PLACEMENT WITH INSIGNIA SINGLE PATIENT KIT. THIS IS THE FIRST OF TWO (2) REPORTS.