MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS, OVERSIZED; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number	CHG026
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Within the scope evaluation for a product field action, this case was identified to have the potential to exhibit the hazard of the recommended screw length being greater than the bone thickness for implants with screw holes located in an area of thin bone.No adverse consequences were reported for this event.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: the reported incident could not be confirmed.Stryker asked the customer to take note of the risks associated with this field action (which were mentioned in the customer notification).In this case, the surgeon confirmed that no adverse consequences were observed.
Event or Problem Description
No new information.

• Brand Name: TMJ BILATERAL IMPLANTS, OVERSIZED
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23716343
• Report Number: 0002031049-2025-00092
• Device Sequence Number: 21078313
• Product Code: LZD
• UDI-Device Identifier: 07613327626568
• UDI-Public: 07613327626568
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/27/2026

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: CHG026
• Device Lot Number: 2306091054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Patient Sex: Unknown