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

Model Number	TYY-NNNRF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient received bilateral implants in (b)(6) 2006.The patient developed pain and swelling on the right side.The surgeon explored the right joint on (b)(6) 2020 and removed the right tmj devices due to suspected infection that caused brown fluid to develop around the condylar.The surgeon may place revisions devices once the infection has been resolved.Multiple mdr reports were filed for this event.Please see the associated report: 2031049-2020-00022.
Event or Problem Description
The patient's right tmj devices were removed due to a suspected infection that was causing pain and swelling.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Common Device Name: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• MDR Report Key: 9931644
• Report Number: 2031049-2020-00021
• Device Sequence Number: 16745513
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3080101W9910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2008
• Device Model Number: TYY-NNNRF
• Device Catalogue Number: TYY-NNNRF
• Device Lot Number: W09910
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR