MAUDE Adverse Event Report: BRASSELER USA H34L.31.012 LONG CROWN CTR; CARBBIDE BURS

Catalog Number 019425U7

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

The doctor recently had several h34l.31.012 burs break while cutting off a pfm bridge and was using on the metal portion.There were no injuries.·.

• Brand Name: H34L.31.012 LONG CROWN CTR
• Type of Device: CARBBIDE BURS
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12181983
• MDR Text Key: 264054128
• Report Number: 1032227-2021-00013
• 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
• Type of Report: Initial
• Report Date: 07/16/2021

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: Health Professional
• Device Catalogue Number: 019425U7
• Device Lot Number: LR5R1
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/16/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR