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

Model Number TYY-NNNNRF

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

This patient received bilateral implants in (b)(6) 2017.A review of the ct scan taken after the initial tmj implant surgery showed that both mandibular components and the right fossa component had not been placed in their intended positions and that the right mandibular component was dislocated laterally.Evaluation of the explanted right fossa component indicated that the fossa and mandibular components were not articulating with each other in their intended fashion.The malposition of the right implant components and improper loading of the fossa component are considered to be contributing factors to this device fracture.The surgeon is planning on placing a revision component.

Event Description

The patient's right fossa component was removed due to fracture.

• 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: 7849188
• MDR Text Key: 119325676
• Report Number: 2031049-2018-00020
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Public: +B004TYYNNNNRF0/$$3190801W43065+
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: TYY-NNNNRF
• Device Catalogue Number: TYY-NNNNRF
• Device Lot Number: W43065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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: 22 YR