Tapered Screw-Vent® Implant System 30AT446Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024013612), received between Jan 18, 2023 and Jan 30, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 30, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ABUTMENT WAS LOOSE, WHICH CAUSED THE SCREW TO DEFORM AND COULD NOT BE LOCKED WITH ADDITIONAL FORCE, RESULTING IN FAILURE, SO THE IMPLANT AT TOOTH LOCATION #35 WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263691 ↗
• MalfunctionJan 18, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH MULTIPLE IMPLANTS, AND IMMEDIATELY LOADED AND WORE TEMPORARY CROWNS IN THE AFTERNOON. THERE WAS NO ADVERSE REACTION AFTER THE OPERATION. SIX MONTHS LATER, WHEN THE PATIENT RETURNED TO THE CLINIC, IT WAS FOUND THAT THE SCREW WAS DEFORMED DUE TO LOOSE ABUTMENT, WHICH COULD NOT BE LOCKED WITH ADDITIONAL FORCE, RESULTING IN FAILURE, SO IT WAS REMOVED. THE CORRESPONDING IMPLANT MODEL IS TSV4B13 WITH THE BATCH OF 63799424. TOOTH SITE # 25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16197911 ↗