MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number CHG020

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Increased Sensitivity (4538); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 08/25/2022

Event Type  Injury  

Event Description

It was reported that the patient was showing material sensitivity to the tmj devices.Surgeon performed a second surgery to clean the joint and insert fat graft.No other information is known at this time.

Manufacturer Narrative

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

Manufacturer Narrative

The event can be confirmed as the surgeon reported that the patient had performed a blood allergy test that showed sensitivity to nickel.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 that the patient was showing material sensitivity to the tmj devices.Surgeon performed a second surgery to clean the joint and insert fat graft.No other information is known 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: 15336331
• MDR Text Key: 299068788
• Report Number: 0002031049-2022-00041
• 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: 12/15/2022

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: T05-152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2005
• 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