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

Model Number	TYY-NNNNRF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369); Joint Dislocation (2374)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon plans to place revision devices at a later time.
Event or Problem Description
It was reported that the patient's right tmj devices were removed due to a fracture in the patient's zygomatic arch.
Additional Manufacturer Narrative
The surgeon performed an open reduction on the right tmj joints where it discovered that the patient's zygomatic arch was fractured.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Common Device Name: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 11468054
• Report Number: 2031049-2021-00016
• Device Sequence Number: 19964247
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3220601W56125
• 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: 2020
• 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): 04/06/2021

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: 06/01/2022
• Device Model Number: TYY-NNNNRF
• Device Catalogue Number: TYY-NNNNRF
• Device Lot Number: W56125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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: 47 YR