MalfunctionELZ
3I INCISE ZR COPING SHADE 3
Received Feb 4, 2015
Report 0001038806-2015-00060 · MDR key 4483181
Device
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
VISUAL EVALUATION OF THE RETURNED COPING CONFIRMED THAT IT HAD FRACTURED. THROUGH THE INVESTIGATION OF THIS COMPLAINT, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO MANUFACTURING DEVIATIONS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED FRACTURE.
Additional Manufacturer Narrative
ADDED DEVICE MANUFACTURE DATE.
Description of Event or Problem
IT WAS REPORTED THAT THE ZIRCONIA COPING FRACTURED DURING PLACEMENT.