MAUDE Adverse Event Report: TOOTH VENEER; TEETH, PORCELAIN

Device Problem Use of Device Problem (1670)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

Veneer covering used by dentist cracked off natural teeth; (b)(6).

• Brand Name: TOOTH VENEER
• Type of Device: TEETH, PORCELAIN
• MDR Report Key: 10338398
• MDR Text Key: 201049487
• Report Number: MW5095781
• Device Sequence Number: 1
• Product Code: ELL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/25/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability