MAUDE Adverse Event Report: CALIBRA UNIVERSAL CEMENT; CEMENT, DENTAL

Catalog Number 607405

Device Problem Unexpected Color (4055)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

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.

Event Description

It was reported that after curing calibra universal translucent, the color was off.The clinician had to remove and replace the material.

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.

• Brand Name: CALIBRA UNIVERSAL CEMENT
• Type of Device: CEMENT, DENTAL
• MDR Report Key: 11606599
• MDR Text Key: 244639355
• Report Number: 2515379-2021-00006
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• PMA/PMN Number: K073173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 607405
• Device Lot Number: 000590592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1