MalfunctionELZ
3I INCISE ZR COPING SHADE 2
Received Jan 13, 2015 · Event occurred Dec 18, 2014
Report 0001038806-2015-00013 · MDR key 4414549
Device
Product problems
- Fracture
- Difficult to Insert
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DR REPORTED THAT THE COPING FRACTURED DURING INSERTION.
Additional Manufacturer Narrative
VISUAL INSPECTION AND DHR REVIEW DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. A DEFINITIVE CAUSE HAS NOT BEEN DETERMINED.(B)(4)