MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD TWO-STEP IMPLANT; BONE SCREW

Catalog Number 204-30-012

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 03/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Multiple attempts to contact the facility regarding the event and investigation have been made.No response or information received as of 11/04/2016.

Event Description

The doctor reported the misplacement of 3 two-step implants.The manufacturer was notified after patient complained of pain and discomfort due to misplacement of implants.

• Brand Name: TWO-STEP IMPLANT
• Type of Device: BONE SCREW
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• Manufacturer (Section G): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• Manufacturer Contact: tyler touchet ; 6721 portwest drive; suite 160; houston, TX 77024 ; 8004952919
• MDR Report Key: 6081466
• MDR Text Key: 59284390
• Report Number: 3007420745-2016-00002
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 204-30-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68