MAUDE Adverse Event Report: BRASSELER U.S.A. DENTAL, LLC CARBIDE FLUTED; BUR, DENTAL

Model Number 14CO608

Device Problem Break (1069)

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

Event Date 10/21/2016

Event Type  malfunction  

Event Description

While in use, the taper carbide fluted standard broke.

• Brand Name: CARBIDE FLUTED
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): BRASSELER U.S.A. DENTAL, LLC; 1 brasseler blvd.; savannah GA 31419
• MDR Report Key: 6208329
• MDR Text Key: 63385517
• Report Number: 6208329
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2016

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: Physician
• Device Expiration Date: 05/19/2021
• Device Model Number: 14CO608
• Device Lot Number: NM5XY
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR