MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT

Model Number	TYY-NNNNM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient developed pain and swelling and decreased range of motion.The surgeon performed an exploratory surgery and discovered a bone screw was loose in the right fossa component and found granulation tissue around the implant.Lab results show the patient has an infection.The surgeon plans to remove the devices.
Event or Problem Description
The surgeon replaced a loose bone screw in the right fossa component.
Event or Problem Description
The surgeon removed the patient's tmj devices due to infection.
Additional Manufacturer Narrative
The pathology tests confirmed that the patient had a propionibacterium acne infection, so the surgeon removed the devices and plans to replace them soon.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Common Device Name: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, LLC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 11729439
• Report Number: 2031049-2021-00024
• Device Sequence Number: 3437291
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W43938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/29/2021

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: 12/01/2019
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W43938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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: 59 YR