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 Ankylosis (4527)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported the patient experienced heterotopic bone and the plan is to perform a second surgery to place a silicone spacer and rescan for new implants.

Event Description

It was reported the patient experienced heterotopic bone and the plan is to perform a second surgery to place a silicone spacer and rescan for new implants.

Manufacturer Narrative

The reported event could be confirmed as the surgeon provided a ct scan for planning the revision device that showed the right tmj device was removed, and a spacer was implanted.The rough surface of the mandible shows that significant bone was removed, which indicated the prior existing heterotopic bone formation.The engineering department reviewed those images, confirmed that tmj devices were removed, and recommended the surgeon to place a fat graft after implanting the new devices to prevent ankylosis again.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issues.Therefore, no corrective and/or preventive actions are deemed necessary 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: 17165685
• MDR Text Key: 317531815
• Report Number: 0002031049-2023-00049
• 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: 08/23/2023

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: T18-0769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• 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