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 Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/28/2024

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 by the patient that post operatively, they were experiencing pain and loss of mouth opening.

Event Description

It was reported, by the patient.That post operatively, they were experiencing pain and loss of mouth opening.

Manufacturer Narrative

The reported event has been confirmed.The images received, show heterotopic bone formation around the joint.Which medical experts confirmed.The device history records ((b)(6)) were reviewed, including the manufacturing documents and inspection specification.All devices met specifications.It could be confirmed, in this investigation, that this issue was not related to the tmj devices.Conclusively, the information received does not suggest a device failure, malfunction or other performance issues.Based on the investigation, there is no indication of an incorrectly working product or any design, material or manufacturing-related issue.

• 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: 19133391
• MDR Text Key: 340484335
• Report Number: 0002031049-2024-00040
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CHG010
• Device Lot Number: T11-495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 03/30/2024
• Supplement Dates FDA Received: 07/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female