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

Model Number	VBEAR-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	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on 29apr2025 that while reviewing post-op x-rays, the surgeon noticed the bearings on the vbear-3-7s had collapsed.It was reported that the intra-op x-rays taken on (b)(6) 2025 looked good for the plate and revision surgery occurred on (b)(6) 2025.It was reported that the original surgery was performed by a fellow with an experienced rep in the room, the proximal screws were not implanted since the fellow felt the distal row fixation was adequate and believed all bearings were locked.It was stated that the patient was compliant with post-op instructions.Intra-op and post-op x-rays were provided but pre-op x-rays could not be obtained and the device will be returned for evaluation.

• Brand Name: VOLAR BEARING PLATE, 3-HOLE, RT
• Common Device Name: VOLAR BEARING PLATE, 3-HOLE, RT
• 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 91355
• MDR Report Key: 22079951
• Report Number: 2031009-2025-00010
• Device Sequence Number: 8702256
• Product Code: HRS
• UDI-Device Identifier: 00842188125027
• UDI-Public: 00842188125027
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: VBEAR-3-7S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• 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