Tapered Screw-Vent® Implant System 15AT323Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024012042), received between Jul 9, 2021 and Sep 16, 2025 — classified as 2 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED TWO ABUTMENTS FRACTURED. PATIENT CAME TO THE CLINIC WITH SCREWS IN HAND. ABUTMENTS WERE PLACED ON (B)(6) 2016 AND REMOVED ON (B)(6) 2025. THE PROCESS WAS COMPLETED WITH OTHER ABUTMENTS, TOOTH LOCATION 12 AND 22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063414 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED TWO ABUTMENTS FRACTURED. PATIENT CAME TO THE CLINIC WITH SCREWS IN HAND. ABUTMENTS WERE PLACED ON (B)(6) 2016 AND REMOVED ON (B)(6) 2025. THE PROCESS WAS COMPLETED WITH OTHER ABUTMENTS, TOOTH LOCATION 12 AND 22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063065 ↗
• InjuryJan 26, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED ABUTMENT LOOSENING+ SCREW DEFORMED WHEN TRY TO TIGHT. SEVERAL IMPLANTS WERE IMPLANTED ON (B)(6) 2022. THE IMMEDIATE LOADING WAS PERFORMED IN THE AFTERNOON. THE RESTORATION WAS DELIVERED. THERE WAS NO ADVERSE REACTIONS AFTER SURGERY. THE PATIENT CAME FOR RE-EXAMINATION ON (B)(6) 2023. THE ABUTMENT LOOSENING WAS FOUND, LEADING TO THE SCREW DEFORMED. THE FORCE COULD NOT BE APPLIED AND LOCKED TIGHTLY, LEADING TO THE FAILURE. THE IMPLANT WAS THEN REMOVED. THE CORRESPONDING NUMBER WAS TSV4B11. THE BATCH NUMBER WAS 63850943. TOOTH SITE # 44-45.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588299 ↗
• InjuryJan 26, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED ABUTMENT LOOSENING+ SCREW DEFORMED WHEN TRY TO TIGHT. SEVERAL IMPLANTS WERE IMPLANTED ON (B)(6) 2022. THE IMMEDIATE LOADING WAS PERFORMED IN THE AFTERNOON. THE RESTORATION WAS DELIVERED. THERE WAS NO ADVERSE REACTIONS AFTER SURGERY. THE PATIENT CAME FOR RE-EXAMINATION ON (B)(6) 2023. THE ABUTMENT LOOSENING WAS FOUND, LEADING TO THE SCREW DEFORMED. THE FORCE COULD NOT BE APPLIED AND LOCKED TIGHTLY, LEADING TO THE FAILURE. THE IMPLANT WAS THEN REMOVED. THE CORRESPONDING NUMBER WAS TSV4B11. THE BATCH NUMBER WAS 63850943. TOOTH SITE # 44-45.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587573 ↗
• MalfunctionJul 9, 2021Component Missing; Component Missing

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146725 ↗