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

Model Number	VBEAL-3-7S
Medical Device Problem Codes	Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on 03aug2025 that the distal screws collapsed in a vbeal-3-7s.Original implant date is unknown.Additional information was provided on 12aug2025 where the rep stated no devices broke, this was not a removal surgery, the device remains implanted and there was no reported adverse event.A second follow-up on (b)(6) 2025 indicated that there is no revision surgery planned, there is no patient discomfort and the surgeon believes the patient will heal properly while leaving the plate insitu.Trimed followed up again on (b)(6) 2025 to gather additional x-rays and more insight on how this issue was discovered by the surgeon.An x-ray was provided on (b)(6) 2025, which shows the plate is partially fixed to the bone with no details on the date and time of the x-ray.Plate still remains implanted and will not 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
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; valencia CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia
• MDR Report Key: 22925953
• Report Number: 2031009-2025-00023
• Device Sequence Number: 13070389
• Product Code: HRS
• UDI-Device Identifier: 00842188124938
• UDI-Public: 00842188124938
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K222637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/29/2025

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: VBEAL-3-7S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 08/29/2025
• 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