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

Model Number TYY-NNNNRM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Joint Dislocation (2374)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

The surgeon plans to place revision components at a later time.

Event Description

It was reported that the patient's right tmj devices were removed due to a fracture in the patient's zygomatic arch.

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 MANDIBULAR COMPONENT
• Type of Device: RIGHT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 11468056
• MDR Text Key: 239384451
• Report Number: 2031049-2021-00017
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: TYY-NNNNRM
• Device Catalogue Number: TYY-NNNNRM
• Device Lot Number: W56126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR