SSW CARBIDE FG-PBUR-1558SLRecalls & reported problems
Ss White Burs, Inc. · FG SL CARBIDE 1558 - 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 D6901406052), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2025Material Fragmentation; Material Fragmentation
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.
Patient problems: Foreign Body In Patient
MAUDE report 22323746 ↗
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- TC cavity Burs Round E012324101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- NA 2296100212Stryker Corporation · BUR, DENTAL2 reports
- TC cavity Burs Round E012334101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
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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