MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT

Model Number TNN-NNNNRF

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

This patient received bilateral tmj implants in (b)(6) 2016.The patient suffered from a trauma incident on her right side and started to experience intermittent swelling.A ct was taken and it showed that the right fossa component was fractured.The surgeon explored the joint, took tissue samples for microbiological testing to rule out any infection, and removed the loose screw on (b)(6) 2018.According to the surgeon, the joint did not look infected and he plans on placing a revision component at a later date.

Event Description

The patient's right fossa component is fractured.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Type of Device: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer Contact: gregory rose ; 2233 knoll drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 8220337
• MDR Text Key: 132203798
• Report Number: 2031049-2019-00001
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3180601W37615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: TNN-NNNNRF
• Device Catalogue Number: TNN-NNNNRF
• Device Lot Number: W37615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR