MAUDE Adverse Event Report: CALIBRA CERAM TRANSLUSCENT; CEMENT, DENTAL

Catalog Number 607194K

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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.

Event Description

It was reported that after curing calibra ceram translucent, the color was off.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

This event was submitted in error and does not meet the criteria for a reportable event.Please diregard the original report.

• Brand Name: CALIBRA CERAM TRANSLUSCENT
• Type of Device: CEMENT, DENTAL
• MDR Report Key: 11510178
• MDR Text Key: 245098000
• Report Number: 2515379-2021-00004
• 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: foreign,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: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 607194K
• Device Lot Number: 00057772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1