MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. TMJ CONCEPTS TOTAL JOINT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994); Numbness (2415)

Event Date 09/23/2015

Event Type  Injury  

Event Description

Pt had a unilateral tmj concepts device put in on (b)(6) 2015.Developed numbness from her forehead to chin.Her eye would not shut all of the way.In 2016 the dr say heterotopic bone growing on the implant.She is now experiencing more numbness, palsy, migraines, sharp stabbing pain, face drooping.She experiences a metallic taste in her mouth since the implant.Tmj concepts said she must get the bone removed and she has a 50/50 chance of saving the implant.

• Brand Name: TMJ CONCEPTS TOTAL JOINT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.
• MDR Report Key: 8008880
• MDR Text Key: 125294556
• Report Number: MW5080815
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability