MAUDE Adverse Event Report: MRNA MANDIBULAR ADVANCEMENT DEVICE; DEVICE, ANTI-SNORING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/12/2021

Event Description

Patient experienced locking of the jaw while chewing, popping and pain.Use of the device was discontinued but the symptoms persisted.The labeling warns about this possible complication which applies to all mandibular advancement devices.It is reversible upon adjustment by a dds.Patient is also told by the dds to return monthly for adjustments to the appliance.Patient has never notified the dds or returned to the ddds but stopped wearing the device when she experienced pain.Patient decided not to return to the dds for personal reasons, so dds appears to be unaware of the problem.Report was submitted anonymously to the fda by patient, so vivos therapeutics does not have a udi number and cannot identify the manufacturer.Vivos could recommend another dental practitioner who could work with the patient to relieve the pain if the fda could provide her with vivos contact information.Fda safety report id # (b)(4).

• Brand Name: MRNA MANDIBULAR ADVANCEMENT DEVICE
• Type of Device: DEVICE, ANTI-SNORING
• MDR Report Key: 13721267
• MDR Text Key: 287029230
• Report Number: MW5108020
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other