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

Model Number	300-52-005
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
One of trilliant's senior r and d engineers went to observe a 300-52-002 broken plate removal with our sales representative.The surgeon suspected non-compliance and the possibility that the patient was not using their orthopedic boot at approximately 2 weeks post-op.Although a "hard" union had not occurred, a "soft" union occurred.It is visible on the x-ray that the most lateral plate hole was not filed in with a gridlock screw.The joint was re-prepped and re-plated with another 300-52-002 plate.All the plating holes were filled in, although a lag screw was not utilized in the re-plating case.The medium talar dome graft was also utilized under the new plate to promote healing.

• Brand Name: PETITE MPJ GRIDLOCK PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 727 n. shepherd dr.; suite 100; houston TX 77007
• MDR Report Key: 7172763
• Report Number: 3007420745-2018-00001
• Device Sequence Number: 854301
• Product Code: HRS
• UDI-Device Identifier: 00812926025360
• UDI-Public: (01)00812926025360(10)TSL004624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 300-52-005
• Device Catalogue Number: 300-52-005
• Device Lot Number: TSL004624
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/08/2018
• 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: 51 YR