LEVEL ONE TRANSBUCCAL 25-472-05-07Recalls & reported problems
KLS-Martin L.P. · CANNULA, 2.0/2.7 MM, W/HANDLE · 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 00888118041357), received between Oct 3, 2018 and Oct 3, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature Problem” (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.
Most reported problems
Device problems
- Temperature Problem1
- Use of Device Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2018Use of Device Problem; Temperature Problem; Use of Device Problem; Temperature Problem
IT WAS REPORTED A PATIENT WAS BURNED WHILE USING A TWIST DRILL AND TROCAR. THE TWIST DRILL WAS BEING USED AT 20,000 RMPS. IT IS STATED IN IFU (B)(4) "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: Burn(s)
MAUDE report 7931134 ↗
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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