MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS BONE SCREW 2.0MM X 8MM, 5 PACK; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number	65-2008
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
It was reported that a revision surgery was required due to the loss of multiple screws in both the fossa and ramus fixtures, which resulted from unusual pressure on the prosthesis.
Additional Manufacturer Narrative
The reported event could not be confirmed.However, the planning scans for the second surgery show 4 loose screws in the right fossa and 2 loose screws in the left fossa component.The right mandibular component including all screws were removed.The post-op scans revealed that the surgeon used pmma bone cement on both sides to stabilize the fossa components, which is highly unusual, and both components appear unstable - one loose on the right and the left collapsed laterally with partial loss of the zygomatic arch.Due to unclear details about the initial surgery, canceled communication, and the surgeon¿s suspension, the root cause of the component loosening could not be determined despite the surgeon attributing it to patient habits.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: BONE SCREW 2.0MM X 8MM, 5 PACK
• Common Device Name: 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 22854768
• Report Number: 0002031049-2025-00069
• Device Sequence Number: 11849728
• Product Code: LZD
• UDI-Device Identifier: 07613327626728
• UDI-Public: 07613327626728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Catalogue Number: 65-2008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown