MAUDE Adverse Event Report: TRIMED INC VOLAR FIXED ANGLE PLATE, LT, 5-HOLE, 7-PEG

Model Number	VPPL-5-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A trimed sales representative reported on (b)(6) 2021 that a broken vppl-5-7 was removed from the patient.The patient had fallen and broke the plate.The initial implantation of the vppl-5-7 was on (b)(6) 2021, the fall and removal occurred sometime in (b)(6).It is believed that prior to the fall, the patient was healing well from the initial surgery.The plate and screws were removed and replaced with bone graft material as well as pins to achieve fixation.It is currently believed that the patient is healing well.Inspection of the device found that the device likely broke due to the impact from the fall and device did not malfunction due to material integrity.

• Brand Name: VOLAR FIXED ANGLE PLATE, LT, 5-HOLE, 7-PEG
• Common Device Name: VOLAR FIXED ANGLE PLATE, LT, 5-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: stephanie rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 12820458
• Report Number: 2031009-2021-00006
• Device Sequence Number: 14821696
• Product Code: HRS
• UDI-Device Identifier: 00842188101755
• UDI-Public: 00842188101755
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: VPPL-5-7
• Device Catalogue Number: VPPL-5-7
• Device Lot Number: CB19074
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown