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

Model Number	VBEAL-3-7W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 28aug2024 that a surgeon experienced a bearing popped out of a vbeal-3-7w.It was reported that the surgeon chose to leave the device implanted without the bearing and the rep does not believe this will cause the patient additional harm.The rep reported that there was about a 45-minute delay in surgery due to having to remove the loose bearing from behind the plate.The rep also reported that there is currently no reported adverse event.No device is available to be returned but x-rays and a picture were provided.When initially reviewing the complaint, we saw that it said the surgeon indicated no additional harm; however, the delay in surgery was overlooked.

• Brand Name: VOLAR BEARING PLATE, 3-HOLE, LT, WIDE
• Common Device Name: VOLAR BEARING PLATE, 3-HOLE, LT, WIDE
• 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: 20340762
• Report Number: 2031009-2024-00004
• Device Sequence Number: 7804940
• Product Code: HRS
• UDI-Device Identifier: 00842188124969
• UDI-Public: 00842188124969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VBEAL-3-7W
• Device Catalogue Number: VBEAL-3-7W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• 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: Other
• Patient Sex: Unknown