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
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
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 manual fossa production ignored instructions to avoid thin bone, resulting in an incorrect screw length and a screw in the cranial vault.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.The reported event could be confirmed based on the provided post op scan.During surgery, a 6mm screw was placed in an area with thinner bone (~2.6mm) than intended, penetrating the cranial vault due to incorrect screw hole positioning that deviated from the approved fossa design mock-up.This issue arose from manual placement challenges in the wax department and ambiguity in screw length recommendations.Conclusively, the event is a manufacturing-related issue.

• Brand Name: BONE SCREW 2.0MM X 6MM, 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: 21662976
• Report Number: 0002031049-2025-00021
• Device Sequence Number: 8737316
• Product Code: LZD
• UDI-Device Identifier: 07613327626711
• UDI-Public: 07613327626711
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/17/2025

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?: No
• Device Catalogue Number: 65-2006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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: Other
• Patient Sex: Unknown