MAUDE Adverse Event Report: TRIMED, INC. VOLARBEARINGPLATE,LT,7-HOLE,7-PEG

Model Number	VLBPL-7-7
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A regional sales manager reported on 25sep2024 that a rep reported that a surgeon implanted a trimed plate (date unknown) and after the patient fell, their radius broke proximal to the plate.This led to a revision surgery (date unknown) and larger plate, vlbpl-7-7 was implanted.It was stated that after the revision surgery, the patient fell again and bent plate.On (b)(6) 2024 the plate was removed and discoloration of bone and tissue was evident.The surgeon stated that it had similar appearance to metalosis.The surgeon ultimately chose to implant another plate from a competitor.Pictures were provided, x-rays were requested but not provided and the device was discarded by the facility.As of 24oct2024 trimed continues to request information from the rep to clarify timelines and information provided by the regional sales manager and the sales rep.

• Brand Name: VOLARBEARINGPLATE,LT,7-HOLE,7-PEG
• Common Device Name: VOLARBEARINGPLATE,LT,7-HOLE,7-PEG
• 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
• MDR Report Key: 20528418
• Report Number: 2031009-2024-00007
• Device Sequence Number: 9088241
• Product Code: HRS
• UDI-Device Identifier: 00842188101595
• UDI-Public: 00842188101595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: VLBPL-7-7
• Device Catalogue Number: VLBPL-7-7
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/24/2024
• 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 Sex: Unknown