MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD 9 HOLE VL GRIDLOCK FIBULA PLATE; PLATE, FIXATION, BONE

Catalog Number 300-60-002

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

The ankle fracture plate was implanted within the last 4 months, according to the sales representative.The patient fell 3 times with the plate and came back to the er after the last fall, which led to an x-ray that showed the broken plate.The doctor removed and replaced the plate.

• Brand Name: 9 HOLE VL GRIDLOCK FIBULA PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• Manufacturer (Section G): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• Manufacturer Contact: tyler touchet ; 6721 portwest drive; suite 160; houston, TX 77024
• MDR Report Key: 6529655
• MDR Text Key: 74102326
• Report Number: 3007420745-2017-00004
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00812926025445
• UDI-Public: 00812926025445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 300-60-002
• Device Lot Number: TSL002873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2017
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 68