Tapered Screw-Vent® TSVTWH11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024344358), received between Sep 11, 2020 and Jun 4, 2026 — classified as 5 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A YEAR AFTER PLACEMENT, PATIENT HAD PROPHY APPOINTMENT AND WE NOTICED INFECTION AROUND GUM OF #18. (WATCHED) CONTINUED IRRITATION AND INFECTION BUMP AND REFERRAL TO PERIODONTIST. AFTER CONSISTENT RE-INFECTION IMPLANT WAS REMOVED. SYMPTOM: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25399949 ↗
• MalfunctionSep 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE THREADS INSIDE OF THE IMPLANT AT TOOTH SITE #12 ARE STRIPPED, NOT ALLOWING THE ABUTMENT TO SEAT. LOOKING TO GET SOMETHING TO RETHREAD THE IMPLANT ALLOWING FOR THE ABUTMENT TO SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050663 ↗
• InjuryJan 16, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172458 ↗
• InjuryJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE. IMPLANT RIM FRACTURE OCCURRED AFTER RESTORATION PLACED. TOOTH NUMBER 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102297 ↗
• InjuryAug 26, 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 #29 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20069564 ↗
• InjurySep 11, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (TSVTWH11) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 19. PATIENT WILL RETURN FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Code Available

  MAUDE report 10524757 ↗