Tapered Screw-Vent® HXL1.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024015425), received between Nov 19, 2021 and Jun 9, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Fracture; Fracture

  THE DOCTOR REPORTS THAT THE SCREWDRIVER BROKE CLEANLY DURING THE TIGHTENING PROCEDURE. THE DOCTOR REPORTS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AND THAT THE PROCEDURE WAS CONCLUDED WITH ANOTHER TOOL DUE TO INVESTIGATION RESULTS, IT WAS CONFIRMED THAT THE DRIVER TIP FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641332 ↗
• MalfunctionMay 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT TOOL HEX FRACTURED AT THE TIP OF THE TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447144 ↗
• MalfunctionApr 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT THEY WERE TRYING TO REMOVE A HEALING ABUTMENT AND THAT'S WHERE THE DRIVER FRACTURED AT THE TIP. THE HEALING ABUTMENT WAS NOT ABLE TO BE REMOVED, AND IS STILL IN THE PATIENT'S MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051719 ↗
• MalfunctionNov 19, 2021Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843408 ↗