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

Catalog Number CHG010

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

Patient Problems Pain (1994); Ankylosis (4527)

Event Date 01/12/2024

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 : not available.

Event Description

It was reported there will be a revision surgery to remove the device.

Manufacturer Narrative

The reported event has been confirmed as the surgeon provided images clearly showing the removal of the left tmj device.This patient initially received a unilateral tmj device on the left side on (b)(6) 2020.Subsequently, the patient developed heterotopic bone, prompting consultation with another surgeon.The surgeon undertook the removal of the left tmj devices along with the heterotopic bone and proceeded to order new left tmj devices.The surgeon's claims, coupled with the provided images, affirms that the removal of the device was attributed to the presence of heterotopic bone.There is no evidence indicating device failure or adverse effects directly related to the device.Consequently, it can be concluded that this event is primarily associated with the patient's underlying condition.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 there will be a revision surgery to remove the device.

• Brand Name: TMJ UNILATERAL IMPLANT
• 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: 18574725
• MDR Text Key: 333634779
• Report Number: 0002031049-2024-00009
• 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: 05/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CHG010
• Device Lot Number: T20-0818 / NEW ID UNDER 240112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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