MAUDE Adverse Event Report: DENTSPLY LLC CALIBRA VENEER KIT W/P&B XP; CEMENT, DENTAL

Catalog Number 607500

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that calibra veneer kit w/p&b xp has discolored/turned black in the area where placed.Device being returned.

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.This event, therefore, is reportable per 21cfr 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.

Manufacturer Narrative

Investigation/inspection found: appearance (return) - passcolor - pass.Dhr review - pass.Appearance (retain) - passcolor - pass.No defect proven - no failure found.

• Brand Name: CALIBRA VENEER KIT W/P&B XP
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13919335
• MDR Text Key: 297862571
• Report Number: 2515379-2022-00041
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 607500
• Device Lot Number: 00086092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/22/2022
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1