Tapered Screw-Vent® TSVT6H13Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024344266), received between Apr 23, 2020 and Jan 16, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24096730 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 23050894 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 21729447 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED SCREW FROM FMT5 WAS NOT SECURE WHEN REMOVING FROM PACKAGE. CAUSED IMPLANT TO DROP ON GROUND AND NO BE USEABLE. NO SYMPTOMS AS A RESULT OF THE EVENT. DOCTOR INDICATED NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418655 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 SUFFERED FROM BONE LOSS & INFECTION AND WAS REMOVED. TOOTH SITE #14 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19132266 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 (UNIVERSAL) WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16435475 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE TSVT6H13 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE # 14 (UNIVERSAL). PATIENT WAS GRAFTED WITH ALLOGRAFT AND SENT HOME.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11531807 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT ACHIEVE PRIMARY STABILITY. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS NOT PLACED. TOOTH LOCATION 18.

  Patient problems: No Information

  MAUDE report 9989997 ↗