MAUDE Adverse Event Report: TRIMED, INC. VOLAR BEARING PLATE, 3-HOLE, LT

Model Number	VBEAL-3-7S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales rep reported on 09jul2025 that when the surgeon was removing a vbeal-3-7s, the distal screws in the plate would not disengage from the bearings.It was reported that this caused a significant delay in the case (over 20 mins).The surgeon was able to eventually remove the plate even though all screws were not able to disengage.Additional information was received on 22jul2025 which the rep stated the surgeon suspects the patient did fall post-op.He directed this inquiry to the patient, however, the patient denied this occurred.The surgeon also noticed the patient was no longer wearing his splint when he arrived for a post-op visit which the surgeon thought was suspicious.The surgeon revealed he gave the patient specific instructions to not remove the splint.Finally, it was confirmed that there was cause for removal of the plate.X- rays and clinic notes from physical exam on (b)(6) 2025 identified loss of fixation as well as prominence on the distal end of the volar bearing plate.The fracture had healed in a poor position because of hardware failure which caused patient discomfort.Also, the surgeon reported during removal the distal row of screws appeared misaligned from their original placement making screw head access difficult.He concluded misalignment implied failure of the bearings within the volar plate.The surgeon ultimately replaced the hardware with medartis adaptive ii trilock volar distal radius plate.Pictures and x-rays were provided and the device is available to be returned.

• Brand Name: VOLAR BEARING PLATE, 3-HOLE, LT
• Common Device Name: VOLAR BEARING PLATE, 3-HOLE, LT
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia, CA
• MDR Report Key: 22688403
• Report Number: 2031009-2025-00020
• Device Sequence Number: 6014309
• Product Code: HRS
• UDI-Device Identifier: 00842188124938
• UDI-Public: 00842188124938
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: VBEAL-3-7S
• Device Lot Number: ME24057
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• 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
• Patient Sex: Unknown