MAUDE Adverse Event Report: SS WHITE BURS LLC SS WHITE CARBIDE BUR; DENTAL BUR

Model Number	FG-PBUR-330
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted on product from the same lot as the reported device was retrieved and evaluated.Dimensional inspection confirmed that the shank diameters were within specifications and met all applicable acceptance criteria.Based on the available information, a definitive root cause is unknown.
Event or Problem Description
Ss white was made aware on october 23, 2025, that during a dental procedure that was performed on an unknown date, the dentist stated that the carbide bur that was used (fg330) was "loose and slipping".While the dentist was using this bur on the patient, the bur slipped down the patient's throat and the patient had to have x-rays done.

• Brand Name: SS WHITE CARBIDE BUR
• Common Device Name: DENTAL BUR
• Manufacturer (Section D): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer (Section G): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer Contact: mariam sawaqed ; 1145 towbin ave; lakewood 08701
• MDR Report Key: 23610016
• Report Number: 2245654-2025-00014
• Device Sequence Number: 13062359
• Product Code: EJL
• UDI-Device Identifier: D690133302
• UDI-Public: D690133302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG-PBUR-330
• Device Catalogue Number: 13330
• Device Lot Number: L05I
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown