MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number CHG020

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

Patient Problem Swelling/ Edema (4577)

Event Date 11/22/2023

Event Type  Injury  

Event Description

It was reported that the patient developed swelling on the right side around the joint after performing unrelated surgery.There is no other information at this time.

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : implanted.

Manufacturer Narrative

The device was sterilized before shipping (b2132), and no abnormality in the sterilization process was reported.The device was shipped without any issues.Thus, the cause of this event is undetermined.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue related to the tmj devices.

Event Description

It was reported that the patient developed swelling on the right side around the joint after performing unrelated surgery.There is no other information at this time.

• Brand Name: TMJ BILATERAL IMPLANTS
• Type of Device: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Manufacturer (Section D): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer (Section G): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer Contact: rylee koole ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 18326485
• MDR Text Key: 330498048
• Report Number: 0002031049-2023-00097
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CHG020
• Device Lot Number: 2110281040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other