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

Catalog Number CHG020

Device Problems Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that it was noticed post operatively the surgeon noticed a discrepancy at the tmj fossa component and the screws did not bind which resulted in a second surgery to remove the screws.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.

Event Description

It was reported that it was noticed post operatively the surgeon noticed a discrepancy at the tmj fossa component and the screws did not bind which resulted in a second surgery to remove the screws.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Per information received, this complaint is considered as an inquiry; therefore, the mdr filed is not correct.The tmj product did not cause or contribute to the reported event and the surgeon confirmed that this event would not have long-term consequences for the patient.The complaint will be reassessed if we receive any new information.

• 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: 16497681
• MDR Text Key: 310822512
• Report Number: 0002031049-2023-00012
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 06/07/2023

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: 2209161051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 06/07/2023
• 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