MAUDE Adverse Event Report: ORAL SURGICAL BURS - FG EXTRA LONG /SURGICAL ROUND END, 5/PKG; BUR, DENTAL

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

Failure of the 557 surgical burs - burs are breaking at the neck / head area with the shank intact.Patterson companies, inc.Fda safety report id# (b)(4).

• Brand Name: ORAL SURGICAL BURS - FG EXTRA LONG /SURGICAL ROUND END, 5/PKG
• Type of Device: BUR, DENTAL
• MDR Report Key: 9279606
• MDR Text Key: 165269212
• Report Number: MW5090872
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1