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

Catalog Number	300-52-004
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A patient (a (b)(6) old male) came into the office during a follow up appointment after having an mpj fusion on (b)(6) 2016.When x-rays were taken of the surgical site during the follow up, it was noticed that the right petite mpj plate had broken in the patient.The patient said he had experienced some pain once it was noted that the plate was broken.According to the doctor, the patient was healing fine initially and might not have been fully compliant.A fusion was not complete and there was some deviation.The doctor talked with the patient regarding the situation and the patient does not want surgery at this time.The doctor decided the deviation was not severe enough to make a surgery mandatory at this time.The doctor will continue to monitor the patient and the plate.

• Brand Name: PETITE MPJ VLC GRIDLOCK PLATE RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• MDR Report Key: 6529382
• Report Number: 3007420745-2017-00002
• Device Sequence Number: 323992
• Product Code: HRS
• UDI-Device Identifier: 00812926025353
• UDI-Public: 00812926025353
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/28/2017
• Report Date (Section F): 02/14/2017

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: No Information
• Device Catalogue Number: 300-52-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 91