MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS BONE SCREW 2.0MM X 6MM, 5 PACK; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number 65-2006

Device Problem Loss of Osseointegration (2408)

Patient Problem Joint Dislocation (2374)

Event Date 08/31/2023

Event Type  Injury  

Event Description

It was reported there will be a revision surgery to remove the implant and screws.

Manufacturer Narrative

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

Manufacturer Narrative

A post-operative image shows that 3 screws of the right mandible tmj implant component are loose.Therefore, the reported loosening of the screws can be confirmed.It has been previously reported by a related engineer that the patient has rheumatic arthritis, which may have contributed to the loss of fixation.

Event Description

It was reported there will be a revision surgery to remove the implant and screws.

• Brand Name: BONE SCREW 2.0MM X 6MM, 5 PACK
• 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: 17843149
• MDR Text Key: 324580361
• Report Number: 0002031049-2023-00079
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 07613327626650
• UDI-Public: 07613327626650
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 65-2006
• Device Lot Number: T21-0663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• 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