CALIBRA UNIVERSAL CEMENT
Received Apr 1, 2021
Report 2515379-2021-00006 · MDR key 11606599
Device
Product problems
- Unexpected Color
Patient
Not reported
- Insufficient Information
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Insufficient Information
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT EVALUATED BECAUSE THIS IS A KNOWN ISSUE WITH THIS LOT/BATCH NUMBER AND A CAPA HAS BEEN OPENED TO CORRECT THE ISSUE.
Additional Manufacturer Narrative
IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. 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 UNIVERSAL TRANSLUCENT, THE COLOR WAS OFF. THE CLINICIAN HAD TO REMOVE AND REPLACE THE MATERIAL.