CALIBRA CERAM TRANSLUSCENT
Received Mar 17, 2021
Report 2515379-2021-00004 · MDR key 11510178
Device
Product problems
- Material Discolored
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
WHILE THERE IS NO INDICATION THAT SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER CURING CALIBRA CERAM TRANSLUCENT, THE COLOR WAS OFF. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.
Additional Manufacturer Narrative
THIS EVENT WAS SUBMITTED IN ERROR AND DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. PLEASE DIREGARD THE ORIGINAL REPORT.