SSW CARBIDE FG-PBUR-330 (REF 13330)Recalls & reported problems
Ss White Burs, Inc. · FG CARBIDE 330 - BULK 100 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D690133302), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
SS WHITE WAS MADE AWARE ON OCTOBER 23, 2025, THAT DURING A DENTAL PROCEDURE THAT WAS PERFORMED ON AN UNKNOWN DATE, THE DENTIST STATED THAT THE CARBIDE BUR THAT WAS USED (FG330) WAS "LOOSE AND SLIPPING". WHILE THE DENTIST WAS USING THIS BUR ON THE PATIENT, THE BUR SLIPPED DOWN THE PATIENT'S THROAT AND THE PATIENT HAD TO HAVE X-RAYS DONE.
Patient problems: Foreign Body In Patient
MAUDE report 23610016 ↗
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- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 2296101421Stryker Corporation · BUR, DENTAL3 reports
- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 1607002105Stryker Corporation · BUR, DENTAL2 reports
- TC cavity Burs Round E012334101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- Zekrya® E014924101600MAILLEFER 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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