MAUDE Adverse Event Report: VILEX, LLC DYNEX; DYNEX SPEED STRUT

Model Number	DF-AS191-303
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported dynex speed strut failure.Distal ends sheared off when engaged with the round portion of the strut.

• Brand Name: DYNEX
• Common Device Name: DYNEX SPEED STRUT
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 8005215002
• MDR Report Key: 24306390
• Report Number: 1051526-2026-00001
• Device Sequence Number: 5314777
• Product Code: KTT
• UDI-Device Identifier: 00841731129857
• UDI-Public: 00841731129857
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: DF-AS191-303
• Device Catalogue Number: DF-AS191-303
• Device Lot Number: 14904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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