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

Model Number	TYY-NNNRF
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A ct was taken and showed that this patient's right tmj devices were removed.Several attempts were made to get more information.A supplement report will be submitted when data is received.Multiple mdrs were submitted for this event (mfr report#2031049-2021-00045).
Event or Problem Description
The patient's right tmj devices were removed due to unknown reasons.
Additional Manufacturer Narrative
The surgeon reported the patient developed severe pain and compression of the auditory canal at the time of the explant surgery.The surgeon stated the devices were stable.
Event or Problem Description
The patient's right tmj devices were removed due to pain.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Common Device Name: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, LLC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 12137459
• Report Number: 2031049-2021-00044
• Device Sequence Number: 14402929
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3151001W23722
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 10/01/2015
• Device Model Number: TYY-NNNRF
• Device Catalogue Number: TYY-NNNRF
• Device Lot Number: W23722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 39 YR