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 06/06/2023

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 : implanted.

Event Description

It was reported the patient has heterotopic bone and there will be a revision surgery taking place.

Manufacturer Narrative

The reported event could be confirmed as the surgeon provided the patient's imaging that showed heterotopic bone around both condyle components of tmj devices.The patient presented to the surgeon with heterotopic bone that needs to be debrided.The surgeon planned to remove the device, debride the joint, and replace a new bilateral set of tmj devices in two-stage surgery.During the investigation it as found that this patient has a history of using different brands of devices, and now she has material sensitivity probably from prior alloplastic devices.Thus, the surgeon plans to implant the mandibular components made entirely from the titanium 6al-4v eli alloy.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issues.

Event Description

It was reported the patient has heterotopic bone and there will be a revision surgery taking place.

• 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: 17183210
• MDR Text Key: 317669419
• Report Number: 0002031049-2023-00050
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• 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: T98-029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/1998
• 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