MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD 4-HOLE STRAIGHT PLATE GRIDLOCK PLATING SYSTEM; BONE PLATE, PRODUCT CODE: HRS

Catalog Number 300-50-005

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

Plate was implanted in mid 2016.Patient reported pain, x-ray revealed the plate was broken.Surgeon noted that there was no union, only fibrous union.Revision was performed on (b)(6) 2017.Surgeon reported that the patient was non-compliant.

• Brand Name: 4-HOLE STRAIGHT PLATE GRIDLOCK PLATING SYSTEM
• Type of Device: BONE PLATE, PRODUCT CODE: HRS
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 727 n. shepherd dr.; suite 100; houston TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LTS; 727 n. shepherd dr.; suite 100; houston TX 77007
• Manufacturer Contact: jodie rodriguez ; 727 n. shepherd dr.; suite 100; houston, TX 77007
• MDR Report Key: 6958825
• MDR Text Key: 90665111
• Report Number: 3007420745-2017-00014
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00812926025407
• UDI-Public: 00812926025407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 300-50-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2017
• Device Age: 15 MO
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 50 YR
• Patient Weight: 113