MAUDE Adverse Event Report: MYOFUNCTIONAL RESEARCH COMPANY USA, INC. MYOBRACE; RETAINER, SCREW EXPANSION, ORTHODONTIC

Device Problems Contamination (1120); Material Disintegration (1177)

Patient Problem Failure of Implant (1924)

Event Date 06/19/2018

Event Type  malfunction  

Event Description

My child used an oral dental device from myofunctional research company.This company is located at (b)(6).The device is known as the "myobrace" "k1" for children ages 5-10.The oral device disintegrates in the mouth after 2-3 weeks of use.The dental office replaced it with a new "k1." it had the same problem again.They then switched my child to a "k2." after a week of usage, i noticed mold developing on the inside of the oral device.My dental office informed me that i should return the myobrace back to the dental office.The dentist then returned the "k2" to myofunctional research company.The dentist said that myofunctional was to evaluate the appliance and test it to see what the problem is.My dentist still hasn't heard back from myofunctional research company.I called the manufacturer and spoke to a lady by the name of (b)(6).She was not helpful.Told me that my child was not cleaning it properly.Very poor support from myofunctional research company.Please contact them.Please take a look at this company.(b)(6).

• Brand Name: MYOBRACE
• Type of Device: RETAINER, SCREW EXPANSION, ORTHODONTIC
• Manufacturer (Section D): MYOFUNCTIONAL RESEARCH COMPANY USA, INC.
• MDR Report Key: 7742847
• MDR Text Key: 116047738
• Report Number: MW5078801
• Device Sequence Number: 3
• Product Code: DYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/30/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Patient Sequence Number: 0
• Patient Age: 8 YR
• Patient Weight: 34