MAUDE Adverse Event Report: TRIMED, INC. VOLAR BEARING PLATE, 5-HOLE, RT

Model Number	VBEAR-5-7S
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 11sep2024 that after an original corrective distal radius osteotomy performed on (b)(6) 2024 the patient presented post op requiring revision surgery on (b)(6) 2024.It was stated that the osteotomy performed and vbear-5-7s was implanted as per surgical technique.It was reported that upon review, it appears the distal screw fixation (screws locked into the bearing) have moved into flexion.This movement subsequently meant the bearing and screw interface shifted not allowing easy screwdriver interface with the screw head.The screws were impeded by the plate itself making extraction difficult.On examination the screws presented tight and locked in the bearing.This affected the 4 distal screws.The surgeon was able to remove screws and supplement with additional fixation.He elected to keep the existing volar bearing plate insitu and insert new screws in the distal row.Prosthesis choice, final technique and fixation made at surgeons' discretion.The surgeon reported that the patient presented with pain and discomfort post op which led to further examination/imaging and thus the revision operation.The surgeon was unsure at the time of the revision surgery if the patient had followed all post op instructions.The rep was not made aware and the surgeon has not declared any existing comorbidities for the patient.

• Brand Name: VOLAR BEARING PLATE, 5-HOLE, RT
• Common Device Name: VOLAR BEARING PLATE, 5-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
• MDR Report Key: 20417758
• Report Number: 2031009-2024-00005
• Device Sequence Number: 8304065
• Product Code: HRS
• UDI-Device Identifier: 00842188125034
• UDI-Public: 00842188125034
• 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: 2024
• Device Explanted Year: 2024
• 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): 10/10/2024

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: VBEAR-5-7S
• Device Catalogue Number: VBEAR-5-7S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• 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