MalfunctionELZ
3I INCISE ZR 3 UNIT FRAMEWORK SHADE 4
Received Jun 5, 2015
Report 0001038806-2015-00701 · MDR key 4820606
Device
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE LAB REPORTED THIS ZIRCONIA COPING FRACTURED POST RESTORATION.
Additional Manufacturer Narrative
UPON INSPECTION, THE COMPLAINT INVESTIGATOR CONFIRMED THIS COPING HAS FRACTURED. INCISE COPINGS ARE DESIGNED OUTSIDE OF BIOMET3I CONTROL. DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEWS DID NOT INDICATE ANY MANUFACTURING DEVIATIONS WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED COMPLAINT.