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

Model Number	FG-558SL
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the head of a surgical bur broke off into the jaw of a patient during a wisdom tooth extraction procedure on (b)(6) 2025.A post-operative image was taken to verify the location of the broken bur which revealed a fragment of the bur was left behind in area #3.It was further reported that retrieval of the fragment of the bur can cause nerve damage as it is close to the ian.A 3dct was taken at a post-op visit showing the fragmented bur appearing to be perforating tissue and working outward near the extraction site.The patient was advised to be aware of tissue sensitivity in right lingual area.Patient was further advised that if she feels a sharp and irritating object, to return to retrieve the bur.Otherwise, patient will return for a six-month follow-up repeat 3dct imaging.A supplemental report will be submitted if additional pertinent information becomes available.
Additional Manufacturer Narrative
The reported bur was not returned for evaluation.However, an investigation was performed on the same part number from a different lot.Neck strength testing on the 20-piece sample was performed and all 20 samples passed.

• Brand Name: SS WHITE CARBIDE BUR
• Common Device Name: DENTAL BUR
• Manufacturer (Section D): SS WHITE BURS LLC; 1145 towbin ave; lakewood NJ 08701
• Manufacturer (Section G): SS WHITE BURS LLC; 1145 towbin ave; lakewood NJ 08701
• Manufacturer Contact: diana hernandez ; 1145 towbin ave; lakewood, NJ 08701 ; 8482226906
• MDR Report Key: 24074949
• Report Number: 2245654-2026-00016
• Device Sequence Number: 10226416
• Product Code: EJL
• UDI-Device Identifier: D6901405852
• UDI-Public: D6901405852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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-558SL
• Device Catalogue Number: 14058-5
• Device Lot Number: L05J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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 Age: 22 YR
• Patient Sex: Female