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

Model Number	FG-PBUR-330
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number reported by the customer does not match lot numbers for any ss white burs llc products, and the reported device was not returned for investigation.However, an investigation was performed using a 20-pc sample of the reported fg-pbur-330 part number was tested for shank diameter and was within specification.
Event or Problem Description
On (b)(6) 2025, customer reported that during a procedure, the bur ejected out of handpiece causing small gingival laceration.It was further reported that the handpiece was set aside, and bur was removed.Ss white burs llc received the medwatch #mw5168269 report from the fda on april 8, 2025.

• 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 avenue; lakewood NJ 08701
• Manufacturer Contact: diana hernandez ; 1145 towbin avenue; lakewood, NJ 08701
• MDR Report Key: 21962459
• Report Number: 2245654-2025-00010
• Device Sequence Number: 7228017
• Product Code: EJL
• UDI-Device Identifier: D690150012
• UDI-Public: D690150012
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 15001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 11 YR
• Patient Sex: Unknown