MAUDE Adverse Event Report: TMJ Solutions, LLC dba TMJ Concepts Bone Screw 2.0mm x 6mm, 5 Pack; Joint, Temporomandibular, Implant

Catalog Number	65-2006
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fossa component could not be properly seated intraoperatively on either the bone or the manufacturing model.The component was unstable and rocked, requiring modification of the surrounding bone to achieve acceptable seating.Postoperative imaging showed areas where full adaptation was not achieved.In addition, remarks were reported regarding screw selection.

• Brand Name: Bone Screw 2.0mm x 6mm, 5 Pack
• Common Device Name: Joint, Temporomandibular, Implant
• 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: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50768323
• Report Number: 0002031049-2026-00103
• Device Sequence Number: 10528850
• Product Code: LZD
• UDI-Device Identifier: 07613327626711
• UDI-Public: 07613327626711
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 65-2006
• Device Lot Number: 1000542559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown