Tapered Screw-Vent® TSVM4H8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024344037), received between Sep 3, 2021 and Jun 3, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT HAD PAIN AND INFLAMMATION AROUND IMPLANT. IMPLANT WAS REMOVED, AND BONE GRAFTING PLACED. PATIENT WILL RETURN TO REPLACE IMPLANT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25382945 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. SITE WAS GRAFTED WITH ALLOGRAFT WHEN IMPLANT REMOVED. TOOTH SITE # 19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14464254 ↗
• MalfunctionApr 6, 2022Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14026919 ↗
• MalfunctionMar 9, 2022Separation Failure; Separation Failure

  DR. INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714057 ↗
• InjurySep 3, 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 #13 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY DURING PLACEMENT. IT WAS IMMEDIATELY FOLLOWING EXTRACTION. THE SITE WAS GRAFTED AND THE PATIENT WAS SENT HOME WITH ANTIBIOTICS TO HEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420822 ↗