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

Model Number	TYY-NNNRF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced a muscle contracture, which resulted in a posterior dislocation of the condyles and perforation into the external auditory canal, which resulted in an infection.The surgeon removed the left tmj devices in (b)(6) of 2016, and the right tmj devices in (b)(6) 2016.Multiple mdr's were submitted for this event.Please reference report 2031049-2020-00054 & 00055 & 00057.
Event or Problem Description
The patient's bilateral tmj devices were removed due to infection.

• 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: 10311764
• Report Number: 2031049-2020-00056
• Device Sequence Number: 860499
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3160401W28958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 04/01/2016
• Device Model Number: TYY-NNNRF
• Device Catalogue Number: TYY-NNNRF
• Device Lot Number: W28958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: 77 YR