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

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994)

Event Date 09/11/2018

Event Type  Injury  

Event Description

Pt has increased pain and migraines post implants (tmj concepts).Pt described pain as a gorilla pounding her in the head on both sides.The pt was told she would have less pain post implants.Pt has daily pain of 7/8/9.She is (b)(6) years old.

• Brand Name: TMJ CONCEPTS
• Type of Device: JOINT, TEMPOROMANDIBULAR IMPLANT
• Manufacturer (Section D): TMJ CONCEPTS / TMJ SOLUTIONS, INC.
• MDR Report Key: 7957085
• MDR Text Key: 123830194
• Report Number: MW5080481
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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; Disability
• Patient Age: 35 YR