MAUDE Adverse Event Report: MANDIBULAR ORTHOPAEDIC REPOSITIONING APPLIANCE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/05/2018

Event Type  Injury  

Event Description

I had tmj symptoms for 6 months and wasn't getting better.I saw a tmj specialist who made a mandibular orthopedic repositioning appliance to fix my bad bite.Now the pain has gotten a lot worse and i now have muscular pain.Custom made by dentist.

• Brand Name: MANDIBULAR ORTHOPAEDIC REPOSITIONING APPLIANCE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• MDR Report Key: 7969150
• MDR Text Key: 123986163
• Report Number: MW5080577
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability