MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD PETITE STEPPED MPJ VLC GRIDLOCK PLATE, LEFT; BONE PLATE

Model Number	300-52-005
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Trilliant sales representatives was informed by the surgery center at (b)(6) that a 300-52-005 plate was broken in a patient that had undergone surgery on (b)(6) 2017.A fusion did not occur and the plate will be removed from the patient on (b)(6) 2017.Follow up with the surgeon by the sales representative, the surgeon suspects the plate breakage was due to patient non-compliance and/or trauma.The patient came into the surgeon's office experiencing pain.The patient has a rather large dog and the patient reported that the dog had pounced or sat on the patient's foot and shortly after that she began to experience pain.

• Brand Name: PETITE STEPPED MPJ VLC GRIDLOCK PLATE, LEFT
• Common Device Name: BONE PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 727 n. shepherd dr.; suite 100; houston TX 77007
• MDR Report Key: 7123137
• Report Number: 3007420745-2017-00016
• Device Sequence Number: 13805709
• Product Code: HRS
• UDI-Device Identifier: 00812926025360
• UDI-Public: (01)00812926025360(11)160719(10)TSL004292
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 300-52-005
• Device Catalogue Number: 300-52-005
• Device Lot Number: TSL004292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR