MalfunctionELZ
3I INCISE ZR COPING SHADE 2
Received Dec 11, 2015 · Event occurred Nov 16, 2015
Report 0001038806-2015-00870 · MDR key 5289960
Device
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
PRODUCT CODE = ELZ.
Description of Event or Problem
THE LAB TECHNICIAN REPORTED THAT THE ZIRCONIA COPING FRACTURED NEAR THE BUCCAL MARGIN AREA 18 MONTHS POST RESTORATION.
Additional Manufacturer Narrative
THE COMPONENT WAS RETURNED AND VISUAL INSPECTION CONFIRMED THAT THE DEVICE HAD FRACTURED. ALTHOUGH AN ORDER NUMBER HAD BEEN PROVIDED, THE ASSOCIATED LOT NUMBER AND DHR INFORMATION CANNOT BE VERIFIED AS PSP-INCISE PRODUCTS ARE NO LONGER MANUFACTURED AT ZIMMER BIOMET. A DEFINITIVE ROOT CAUSE COULD NOT BE VERIFIED. (B)(4)