MalfunctionELZ
3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0
Received Mar 12, 2015
Report 0001038806-2015-00431 · MDR key 4593226
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 ZIRCONIA COPING BRIDGE HAS FRACTURED AFTER IT WAS PLACED IN THE PATIENTS MOUTH.
Additional Manufacturer Narrative
THE REPORTED FRACTURE OF THE 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0 COULD NOT BE VERIFIED, PRODUCT WASN'T RETURNED. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED COMPLAINT. THE DHR WAS REVIEWED, THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT.