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 Problem Ankylosis (4527)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to remove the implant.

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.

Manufacturer Narrative

Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issues.The patient had a small amount of heterotopic bone but had a significant number of scars.After removing the joints and debriding the area, the surgeon still could not mobilize the mandible.

Event Description

It was reported that a revision surgery was performed to remove the implant.

• 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: 17603692
• MDR Text Key: 321745145
• Report Number: 0002031049-2023-00067
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 07613327626551
• UDI-Public: 07613327626551
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• 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: T19-0097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• 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