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 Ankylosis (4527); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported that a second surgery was performed to remove the devices due to heterotopic bone.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could be confirmed as the surgeon sent an order for new devices along with the plan and imaging, which indicated the heterotopic bone around the left tmj devices.The engineering department reviewed the imaging and reported that the patient had an open bite and some heterotopic bone around the joints formed, which is probably the main contributing factor to the revision of the devices.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.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

Event Description

It was reported that a second surgery was performed to remove the devices 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: 15155835
• MDR Text Key: 297147072
• Report Number: 0002031049-2022-00028
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/09/2022

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: T05-176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 11/09/2022
• 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): Required Intervention