Tapered Screw-Vent® TSVM6B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024019690), received between Nov 30, 2020 and Jul 1, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO A FRACTURE AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22370347 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE 19(UNIVERSAL) WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 19288875 ↗
• InjuryMay 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SITE AT TOOTH LOCATION #30 HAS A FRACTURED IMPLANT. IT WAS FOUND IN X-RAY AND ASSUMED IT WAS THE SCREW, BUT IT WAS THE IMPLANT INSTEAD. THE IMPLANT WAS REMOVED AND THE PATIENT WILL RETURN FOR FUTURE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952903 ↗
• InjuryMar 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #3 WAS LOOSE DURING A FOLLOW UP APPOINTMENT AND REMOVED DUE TO A FRACTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND BONE LOSS.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 16462909 ↗
• InjuryJul 1, 2022Adverse 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 AT THE IMPLANT SITE.

  Patient problems: Unspecified Infection

  MAUDE report 14885475 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE # 19 (UNIVERSAL) WAS REMOVED DUE TO INFECTION THAT DEVELOPED DURING HEALING PHASE. SITE WAS GRAFTED WITH ALLOGRAFT. PAIN AND INFLAMMATION ARE REPORTED SYMPTOMS OF THE INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 12207184 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED. NO OTHER IMPLANT WAS PLACED AFTER REMOVAL. SITE WAS GRAFTED.

  Patient problems: No Information

  MAUDE report 10919778 ↗