SSW CARBIDE FG-PBUR-558SLRecalls & reported problems
Ss White Burs, Inc. · FG SL CARBIDE 558 - 5 PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D6901405852), received between Jan 14, 2026 and Jan 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Break; Detachment of Device or Device Component
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.
Patient problems: Foreign Body In Patient; Perforation
MAUDE report 24074949 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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