MAUDE Adverse Event Report: ZYPPAH, INC. ZYPPAH SNORING APPLIANCE; DEVICE, ANTI-SNORING

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

Patient Problem Joint Dislocation (2374)

Event Date 02/05/2020

Event Type  Injury  

Event Description

Permanently misaligned jaw.I have used the zyppah snoring appliance for several years.I have recently been diagnosed (by both prosthodontist and orthodontist) with a serious misalignment of jaw caused by extended use of this device.Both upper and lower teeth have shifted and jaw has move forward.It now requires extensive orthodontia to fix to prevent even more extensive damage to my teeth long term due to misaligned bite.Hcps report that this is a known issue with this product and others like it, yet there are no safety warnings to prevent other consumers form being similarly harmed.Fda safety report id # (b)(4).

• Brand Name: ZYPPAH SNORING APPLIANCE
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): ZYPPAH, INC.
• MDR Report Key: 9686779
• MDR Text Key: 178570707
• Report Number: MW5092870
• 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: Patient
• Type of Report: Initial
• Report Date: 02/05/2020

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: 02/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 64