MAUDE Adverse Event Report: TriMed, Inc. Volar Bearing Plate, 3-Hole, Rt

Catalog Number	VBEAR-3-7S
Medical Device Problem Codes	Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported on (b)(6) 2026 that a surgeon was placing a competitor's dorsal plate due to previous trimed wrist construct failing, this construct included vbear-3-7s with 2.4tpeg and 3.2mm cortical and locking screws.The original trimed wrist construct was implanted on (b)(6) 2026 and removed on (b)(6) 2026.The surgeon was concerned how the distal screws migrated proximally and one of the bearers came out of the plate.The orthopaedic surgeons advised the patient didn't fall prior to the plate removal and no other incidents were reported by the surgeons.It was reported that the patient was was a 67 yr female, it is unknown if the patient has poor bone quality and it is believed she would have comorbidities however unaware of what they are.The revision surgery was successful with no delay in surgery and no additional reported adverse event.

• 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; santa clarita CA 91355
• Manufacturer (Section G): TriMed, Inc.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; +1(661)255-7406
• MDR Report Key: 50934716
• Report Number: 2031009-2026-00015
• Device Sequence Number: 9598007
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Catalogue Number: VBEAR-3-7S
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female