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

Model Number	300-52-004
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon implanted a 300-52-004 petite mpj plate on (b)(6) 2017.The patient came in reporting pain and the surgeon utilized x-rays to discover that the plate was broken and no fusion had occurred.The revision surgery was performed on (b)(6) 2018.According to trilliant's sales representative at the case, the surgeon removed the lag screw and the entire 300-52-004 petite plate and associated screws lifted off the surgical site without the use of the 310-30-003 gridlock driver.The surgeon utilized another companies hardware in the revision surgery.The 300-52-004 petite gridlock plate and associated screws have been retained by the facility as the surgeon wanted to review the hardware with the patient.Trilliant has requested to receive the parts back after the surgeon has finished reviewing the hardware.

• Brand Name: PETITE MPJ GRIDLOCK PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n. shepherd dr.; suite 100; houston TX 77007
• MDR Report Key: 7367929
• Report Number: 3007420745-2018-00003
• Device Sequence Number: 13720121
• Product Code: HRS
• UDI-Device Identifier: 00812926025353
• UDI-Public: (01)00812926025353(10)TSL004509
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: Lay User/Patient
• Device Model Number: 300-52-004
• Device Catalogue Number: 300-52-004
• Device Lot Number: TSL004509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/23/2018
• 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: 59 YR