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 Problems Pain (1994); Ankylosis (4527)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported there was a revision surgery to remove the right side tmj implant due to heterotopic bone.

Manufacturer Narrative

Update: h6.The reported event has been confirmed, as the surgeon provided images clearly showing the removal of the right tmj device.Additionally, the surgeon has initiated the order for revision devices.The patient presented to the surgeon due to severe right tmj pain and limited mouth opening.A ct scan was taken, which showed dystrophic bone growth around the implants and fossa components bilaterally.A month later, the surgeon performed a right tmj osteoplasty removal and replanting of the prosthesis.However, the patient experienced complicated postoperative symptoms, including pain and limited opening.A month later, purulence was noted from the incision site, with gradual improvement and minimal symptom relief.The patient presented again six months later due to recurrent severe right tmj pain on (b)(6) 2023.Consequently, the surgeon removed the right tmj prosthesis on (b)(6) 2023 and placed a stock condyle.However, the patient continued to experience pain and deviation, prompting the surgeon to plan a revision of the right tmj devices.Revision devices are being designed, manufactured, and shipped under id#2401081041.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 was a revision surgery to remove the right side tmj implant due to heterotopic bone.

• 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: 18932883
• MDR Text Key: 338023744
• Report Number: 0002031049-2024-00024
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 07613327626575
• UDI-Public: 07613327626575
• 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: 07/19/2024

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: CHG020
• Device Lot Number: T16-0896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 07/19/2024
• 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