MAUDE Adverse Event Report: DENTEK ORAL CARE, INC DENTEK MAXIMUM PROTECTION DENTAL GUARD; MOUTHGUARD, OVER-THE-COUNTER

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Code Available (3191)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Around the middle of (b)(6) 2018, during my semi-annual cleaning at my dentist office, i was informed by my dentist that my canine teeth were noticeably worn down from grinding my teeth.I had also recently been told by my girlfriend that i occasionally grind my teeth at night and informed my dentist of this.My dentist recommended i wear a mouthguard at night to prevent further damage to my teeth from grinding while sleeping.The cost to have a custom fitted mouthguard made at my dentist¿s office would have been around (b)(6), the administrative staff at my dental office informed me my insurance would not cover the cost.Due to the excessive cost my dentist recommended i try out an over-the-counter mouth guard before paying for a custom fitted guard.Within days of my dental appointment i purchased a dentek maximum protection dental guard from (b)(6).I wore this guard nightly, from mid (b)(6) until (b)(6) 2019 (approximately three months).In the weeks leading up to (b)(6) i began to feel slight changes in my bite and increased difficulty chewing certain foods.Specifically on saturday (b)(6), i noticed increased difficulty in chewing steak tips and lettuce in a salad.On sunday (b)(6), i closely examined my bite in a mirror and noticed that only the back part of my rear molars were able to touch, due to the dental guard i had developed an open bite.I had worn braces about a decade prior and did not have an open bite before using the dental guard.Upon further examination, the dentek guard i was using did not cover my back molars.As a result of my back molars not being in contact with anything at night, due to the dentek guard, they began to rise, causing an open bite.I re-visited my dentist on (b)(6) to discuss the issue i was having.After examining my bite, my dentist agreed that the dental guard had caused my molars to rise and advised me to discontinue wearing it.The current course of action to resolve the open bite, from my dentist, is to not wear any dental guard and see if my teeth are able to re-align themselves and self-correct the open bite.I was told by my dentist that this could take a few months to work.I am writing this report as i believe the dentek guard is a defective product.Any product that does not cover all teeth in the mouth and causes an open bite to form is not a safe and effective product for consumers to be using.An easy fix would be to increase the size of the dental guard so it covers all teeth and can be cut down if too long for certain consumers (it is not possible for a consumer with a larger mouth to increase the length of the product to ensure coverage of all teeth in mouth).Secondly, although the packaging for the product does include a warning to discontinue use if ¿you have a change in your bite that persists for more than a few minutes after removing the product¿, i believe the instructions should be more specific and inform consumers that the guard can cause an open bite if it does not cover all teeth in the mouth.Below is a link to an article of someone that has experienced similar issues with a different dental guard.It appears this is an industry issue that should be addressed by the fda.(b)(6).

• Brand Name: DENTEK MAXIMUM PROTECTION DENTAL GUARD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): DENTEK ORAL CARE, INC
• MDR Report Key: 8366215
• MDR Text Key: 137368528
• Report Number: MW5084277
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 75