MAUDE Adverse Event Report: SS WHITE BURS INC. CARBIDE BUR - DENTAL; BUR-DENTAL

Catalog Number SSW HP-702

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/05/2018

Event Type  Injury  

Event Description

Pt for elective dental extractions; during surgical procedure, tip of surgical bur broke.

• Brand Name: CARBIDE BUR - DENTAL
• Type of Device: BUR-DENTAL
• Manufacturer (Section D): SS WHITE BURS INC.; lakewood NJ 08701
• MDR Report Key: 7872611
• MDR Text Key: 120264353
• Report Number: MW5079777
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSW HP-702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention