MAUDE Adverse Event Report: BRASSELER USA 019425U7 - H34L.31.012 FG L MTL CTR; CARBIDE BURS

Catalog Number 019425U7

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  malfunction  

Event Description

The doctor was using the bur to remove old pfm and reports heads snapping off when it touched the metal.It happened a few times but the one patient he can remember was a female that was 54.The doctor did not keep the broken burs but said most of them that he tried snapped.Reporting out of an abundance of caution, because the complainant could not provide product nor confirm lot/serial information.

• Brand Name: 019425U7 - H34L.31.012 FG L MTL CTR
• Type of Device: CARBIDE BURS
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12231417
• MDR Text Key: 265778024
• Report Number: 1032227-2021-00015
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 019425U7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR