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

Model Number	300-52-004
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came into the surgeon's office experiencing pain and irritation around the surgical site.After the surgeon x-rayed the site, it was visible that the (b)(4) petite mpj plate and the interfrag screw (b)(4) were broken in the patient.The surgeon removed the (b)(4) plate and associated screws.Since a fusion had not occurred, the surgeon utilized a silastic implant on the mpj.Trilliant's sales representative at the removal case, noted that the surgeon stated the proximal phalanx was a bit "soft" when he was inserting the silastic implant.Trilliant's sales representative stated that the (b)(4) plate and screws were inserted approximately eight months ago, although he is checking with the facility to confirm the date of implantation.The (b)(4) plate and screws will be returned to trilliant surgical for review.

• Brand Name: PETITE MPJ VLC RIGHT 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: 7239799
• Report Number: 3007420745-2018-00002
• Device Sequence Number: 1222659
• Product Code: HRS
• UDI-Device Identifier: 00812926025353
• UDI-Public: (01)00812926025353(10)TSL002992
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K123525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: TSL002992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 02/03/2018
• 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