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

Model Number	TYY-NNNNLF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient received bilateral tmj implants in (b)(6) 2017.The patient started to experience mild, periodic pain and swelling on both sides.The surgeon reported that her left side had become infected and that she had developed a draining fistula in early (b)(6) 2018.He debrided the fistula and removed the left fossa component on (b)(6) 2019.Tissue samples were taken for microbiological testing, and the results showed growth of (b)(6).After the infection has resolved, the surgeon will evaluate her occlusion and determine what additional treatment is appropriate.
Event or Problem Description
The patient had surgery to remove the left fossa component due to infection.

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Common Device Name: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• MDR Report Key: 8324335
• Report Number: 2031049-2019-00003
• Device Sequence Number: 16733781
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3181201W38846
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: 12/01/2018
• Device Model Number: TYY-NNNNLF
• Device Catalogue Number: TYY-NNNNLF
• Device Lot Number: W38846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/08/2019
• 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: 18 YR