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

Model Number TYY-NNNRF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Disorder (2373)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

This patient received right tmj devices in (b)(6) 2011.Several years later, the patient started experiencing painful swelling and tenderness over the right ear area.Imaging was taken but it did not show any evidence of hardware failure or infection.The surgeon removed the patient's right fossa component in (b)(6) 2019, and placed an antibiotic spacer.The surgeon reported that the fossa component was stable and well-integrated with the bony anatomy.The explanted device was cultured and results came back normal.The surgeon plans on placing a revision fossa component at a later date.

Event Description

The patient's right fossa component was removed due to pain and swelling.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Type of Device: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura CA 93003 7398
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 9522145
• MDR Text Key: 172904295
• Report Number: 2031049-2019-00059
• Device Sequence Number: 1
• Product Code: LZD
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: TYY-NNNRF
• Device Catalogue Number: TYY-NNNRF
• Device Lot Number: W20978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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: 59 YR