MalfunctionELZ
3I INCISE ZR COPING SHADE 2
Received Mar 10, 2015
Report 0001038806-2015-00331 · MDR key 4584297
Device
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE INCISAL EDGE ON THE INCISE COPING HAS FRACTURED.
Additional Manufacturer Narrative
THERE WERE NO PICTURES OF THE REPORTED FRACTURE PROVIDED BY THE COMPLAINANT, HOWEVER, A CUSTOMER DESIGNED RENDERING WAS PROVIDED. NO LOT NUMBER WAS PROVIDED. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT. SINCE NO PRODUCT OR SUPPORTING INFORMATION WAS PROVIDED THIS COMPLAINT CANNOT BE VERIFIED. THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. (B)(4).
Additional Manufacturer Narrative
COPING NOT RETURNED TO MANUFACTURER. DEVICE NOT RETURNED TO MANUFACTURER