NA 92-19758Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154629442), received between Oct 4, 2019 and Jan 27, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2021Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A, CASE, THE DRILL BIT BROKE WHEN TRYING TO DRILL INTO THE SKULL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11237476 ↗
• MalfunctionAug 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TWIST DRILL BROKE INTRA-OPERATIVELY. A BACKUP DRILL WAS USED TO SUCCESSFULLY COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10402960 ↗
• InjuryOct 4, 2019Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CASE, THE SURGEON WAS PULLING THE DRILL (WITH BIT) OUT OF THE PATIENT'S MOUTH, AND THE BIT WAS BENT WHICH CAUSED THE SURGEON TO CUT THE PATIENT'S MOUTH. THE PATIENT RECEIVED STITCHES.

  Patient problems: Injury

  MAUDE report 9157981 ↗