Tapered Screw-Vent® TSVT4H13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024344211), received between Mar 23, 2022 and Sep 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A FRACTURE AT THE HEX OF THE IMPLANT AT TOOTH LOCATION #5. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 20138692 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CHANGED THEIR RESTORATIVE PLAN FOR THE IMPLANTS IN TOOTH SITES #13, #12 AND #3. DUE TO THIS, THE INITIAL IMPLANTS WERE REMOVED AND WILL NEED TO BE REPLACED IN A MORE IDEAL LOCATION FOR RESTORATIVE GOALS. THE IMPLANTS WERE REMOVED WITH NO COMPLICATIONS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion

  MAUDE report 19664920 ↗
• InjuryOct 7, 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 LOSS OF BUCCAL BONE AT THE IMPLANT SITE.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 15562245 ↗
• InjuryMar 23, 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 PERI-IMPLANTITIS WITH PAIN, AN ABSCESS AND A FISTULA. PATIENT WILL RETURN FOR A NEW IMPLANT. TOOTH #9.

  Patient problems: Abscess; Fistula; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13860819 ↗