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

Model Number	FG-1558SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
It was reported that an oral surgeon learned after the fact that 5mm fragment of the fg-1558sl carbide bur was left in a patient's extraction socket that fully healed over in the bone with no evidence of infection in the area.The patient was concerned about getting an mri with the fragmented piece of the bur left in the area.No patient injury nor medical intervention was reported.

• Brand Name: SS WHITE CARBIDE BUR
• Common Device Name: DENTAL BUR
• Manufacturer (Section D): SS WHITE BURS LLC; 1145 towbin avenue; 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: 22323746
• Report Number: 2245654-2025-00011
• Device Sequence Number: 8857706
• Product Code: EJL
• UDI-Device Identifier: D6901406052
• UDI-Public: D6901406052
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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
• Device Model Number: FG-1558SL
• Device Catalogue Number: 14060-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/24/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown