Tapered Screw-Vent® TSVT4H10Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024344198), received between Jul 2, 2020 and Dec 22, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RETAINING SCREW MALFUNCTIONED AND NO LONGER CLOSES. TOOTH #31. THE DOCTOR SUSPECTS THE INTERNAL SCREW OF THE FIXTURE MAY BE DEFECTIVE. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862844 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED PERI-IMPLANTITIS. THE IMPLANT WAS ALREADY OUT WHEN THE PATIENT PRESENTED TO THE CLINIC. THE FAILURE WAS DUE TO SEVERE BONE LOSS AND INFECTION AND TOOTH SITE #4. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23524572 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION WITHOUT COMPLICATIONS, IMPLANT #12. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21196336 ↗
• InjuryMay 17, 2023Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944810 ↗
• InjuryMay 17, 2023Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944753 ↗
• InjuryMay 17, 2023Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944690 ↗
• InjuryMay 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT COLLAR AT TOOTH LOCATION #5 FRACTURED DURING REPLACEMENT. CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454660 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 12 FAILED TO INTEGRATE AT THE IMPLANT SITE AND WAS REMOVED DUE TO LOW BONE DENSITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12387893 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SITE GRAFTED AND THE PATIENT WILL RETURN IN THE FUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 11531378 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS, INFECTION & BONE LOSS DISCOVERED DURING CLINICAL PROCEDURE.

  Patient problems: Inflammation; Pain

  MAUDE report 11289506 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE THAT REQUIRED IMPLANT REMOVAL. PATIENT WILL NEED TO RETURN FOR A NEW IMPLANT IN THE FUTURE. TOOTH #13.

  Patient problems: Unspecified Infection

  MAUDE report 10223451 ↗