MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD LARGE L PLATE (LEFT) GRIDLOCK PLATING SYSTEM; BONE PLATE, PRODUCT CODE: HRS

Catalog Number	300-56-005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor removed a large vlc "l" plate (left) because of a non-union.The plate was cracked, according to the rep.The doctor removed the plate without any complications.He performed a revision lapidus procedure and used a paragon 28 plate to finish the case.The rep was not able to keep the plate because the patient requested to keep it.The rep was not able to determine the initial implant date though it wsa determined to be a year to a year and a half ago.

• Brand Name: LARGE L PLATE (LEFT) GRIDLOCK PLATING SYSTEM
• Common Device Name: BONE PLATE, PRODUCT CODE: HRS
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• MDR Report Key: 6716715
• Report Number: 3007420745-2017-00012
• Device Sequence Number: 1267577
• Product Code: HRS
• UDI-Device Identifier: 00812926025407
• UDI-Public: 00812926025407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: No Information
• Device Catalogue Number: 300-56-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2017
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68