Tapered Screw-Vent® TSVMH13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024344112), received between May 25, 2022 and Jun 3, 2026 — classified as 4 injuries.

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

• InjuryJun 3, 2026Fracture

  IT WAS REPORTED THAT THE RIM OF THE IMPLANT AT TOOTH SITE #12 BROKE OFF. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25381184 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A THREE-MONTH X-RAY OF THE IMPLANT AT TOOTH SITE #5. THE X-RAY SHOWED INFECTION AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23437052 ↗
• InjuryJun 2, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #35 FAILED BECAUSE IT FRACTURED AT THE NECK. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123236 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT #5 3.7 X 13 TSV PLACED (B)(6) 2022. ALONG WILL #4 IMPLANT BONE GRAFTED FACIAL 5 TO BUCKLAND DEMERIT RIDGE, USED BIOMET + PUROS. IMPLANT REMOVED DUE TO INFECTION, REBONE GRAFTED SITE. CAME OFF STABILIZE INFECTION 5 IMPLANT AREA. FLOPPED AREA. IMPLANT LOOSE; EXUDATE NOTED. DEBRIDED OVER WELL ALONG WITH IMPLANT REMOVAL THEN REGRAFTED AREA WITH PURUS FINE TRABECULAR AND BIOMED. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH #5.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain; Unspecified Infection

  MAUDE report 14502558 ↗