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

Catalog Number CHG020

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Dislocation (2374)

Event Date 09/27/2023

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 : not available.

Event Description

It was reported there was a revision surgery performed to reposition the mandibular implants.

Event Description

It was reported there was a revision surgery performed to reposition the mandibular implants.

Manufacturer Narrative

The surgeon confirmed that he dislocated the left joint when manipulating the maxilla.He added that he implanted the condylar too firmly on the right and pushed the right side back off the lip, which moved the left side down and forward.Hence, the posterior maxilla was off from the plan.Based on the investigation, there is no indication of any incorrectly working product or design, material, or manufacturing-related issue.

• 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: 17950920
• MDR Text Key: 325863312
• Report Number: 0002031049-2023-00084
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 07613327626575
• UDI-Public: 07613327626575
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CHG020
• Device Lot Number: 2304201025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 01/11/2024
• 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