"SNAP ON SMILE" *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-08 for "SNAP ON SMILE" * manufactured by Trident Labs.

Event Text Entries

[585129] Ordered a product through my dentist, called "snap on smile" by trident labs in calif. The product was ill-fitted and inferior. The product broke my back molar and the bottom set cracked upon installation at the dentist's office. I tried to wear the teeth for four hrs and returned them. The lab seemed unconcerned when i called. The dentist said that he would refund my money and then, recanted saying that the "lab would not refund him. " no one has assumed responsibility for my broken tooth -i had just had my teeth cleaned the same day my "teeth" were ordered and the problem did not exist. The co makes false advertising claims. The teeth are flimsy and dangerous. You can not eat or drink with them, as their advertising says. You can not talk with them without sounding inebriated. They should be taken off the market. They are as flimsy as those halloween vampire teeth. Someone could be hurt. The teeth did not come with any warnings or limitations. Ordered on 09/06 and installed 3 weeks later. Returned the product the following week.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1041939
• MDR Report Key: 819354
• Date Received: 2007-02-08
• Date of Report: 2007-02-08
• Date of Event: 2006-09-07
• Date Added to Maude: 2007-02-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: "SNAP ON SMILE"
• Generic Name: DENTURES
• Product Code: NSK
• Date Received: 2007-02-08
• Returned To Mfg: 2006-09-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 806839
• Manufacturer: TRIDENT LABS
• Manufacturer Address: * * CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-02-08