MAUDE Adverse Event Report: STRYKER INSTRUMENTS PROFESS ENT REGISTRATION KIT; NAVIGATION SYSTEM

Catalog Number 6001-420-000

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Skin Tears (2516)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

Completed a sinus case using the new stryker navigation system.Upon removing the stryker profess registration kit headpiece, inspected the patient's tissue integrity and noted skin breakdown on nose bridge bilaterally.The left and right sided wounds were reddened about 1cm x 1cm each and slightly pitted from the metal piece that sits on the patient's face and comes in contact with the patient's upper nose.Ten minutes later, the patient's wound was again assessed and a blister formed on the left sided wound.The right sided wound became less prominent.Applied polymyxin ointment.

• Brand Name: PROFESS ENT REGISTRATION KIT
• Type of Device: NAVIGATION SYSTEM
• Manufacturer (Section D): STRYKER INSTRUMENTS; 750 trade centre way; ste. 200; portage, MI 49002
• MDR Report Key: 4899201
• MDR Text Key: 19431603
• Report Number: 4899201
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 6001-420-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR