LEVEL ONE TRANSBUCCAL 25-471-05-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118041296), received between Feb 15, 2018 and Jan 4, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED A PATIENT WAS BURNED WHILE USING A TWIST DRILL AND TROCAR.

  Patient problems: Burn(s)

  MAUDE report 8217435 ↗
• InjuryFeb 15, 2018Temperature Problem; Device Handling Problem; Temperature Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HEAT BURNS BILATERALLY ON THEIR CHEEKS. THE TWIST DRILL WAS BEING USED AT 35,000 RPM WITH A TROCAR. IT IS STATED IN IFU 90-274-92-40 AND 91-600-00-41 UNDER PRECAUTIONS "WHEN USING TWIST DRILLS, COPIOUS AMOUNTS OF IRRIGATION ARE MANDATORY TO ALLEVIATE EXCESSIVE HEAT GENERATION, WHICH CAN LEAD TO BONE NECROSIS, AND IN EXTREME CASES, SOFT TISSUE BURNS THROUGH CONTACT WITH TROCAR AND CANNULA." AND "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM." THE BURNT TISSUE WAS CUT OUT LIKE A SCAR REVISION.

  Patient problems: Burn(s)

  MAUDE report 7272823 ↗