MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ UNILATERAL IMPLANTS (BUNDLED COST); PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number CHG010

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 04/25/2023

Event Type  Injury  

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.

Event Description

It was reported that the patient experienced a metal hypersensitivity to the implant and the surgeon will be performing a revision surgery.

Manufacturer Narrative

The event can be confirmed as the surgeon provided required documents for fda compassionate use of device approval.The patient did fairly well with the joint replacement from a functional standpoint; however, she has had continual episodes of discomfort, redness, and tenderness associated with the joint.After applying different treatment plans, the surgeon concluded that there may be issues related to one of the non-titanium components in her prosthesis.Orthopedic analysis revealed that the patient was indeed reactive at low levels to nickel.The surgeon plans to remove and revise the right mandibular component.Based on the investigation there is no indication of an incorrectly working product or any design, material or manufacturing related issue.

Event Description

It was reported that the patient experienced a metal hypersensitivity to the implant and the surgeon will be performing a revision surgery.

• Brand Name: TMJ UNILATERAL IMPLANTS (BUNDLED COST)
• 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: 16912948
• MDR Text Key: 315021471
• Report Number: 0002031049-2023-00034
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CHG010
• Device Lot Number: T19-0497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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): Required Intervention