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

Catalog Number 607405

Device Problems Material Discolored (1170); Unexpected Color (4055)

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

Event Type  Injury  

Manufacturer Narrative

Therefore, because intervention was required, this event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned 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 patient returned to the dental office and the crown was recemented without any injury.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: CALIBRA UNIVERSAL CEMENT
• Type of Device: CEMENT, DENTAL
• MDR Report Key: 11646656
• MDR Text Key: 244849800
• Report Number: 2515379-2021-00007
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 607405
• Device Lot Number: 00059092
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention