Tapered Screw-Vent® TSVMH11Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024344105), received between Mar 23, 2022 and Jun 2, 2026 — classified as 7 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 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.

• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTIST NOTED BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #29 AND SENT THE PATIENT TO THE SURGEON. THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25365308 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO BONE LOSS. AN ADDITIONAL APPOINTMENT WAS REQUIRED.

  Patient problems: Osteolysis

  MAUDE report 24595676 ↗
• InjuryMar 5, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED AS IT WAS FRACTURED AT THE HEX. ON (B)(6) 2025, THE PATIENT WAS REFERRED BY THE DOCTOR OF DENTAL SURGERY TO EXPLORE THE IMPLANT. THE ABUTMENT SCREW WAS LOOSE BUT THE DOCTOR WAS UNABLE TO REMOVE IT. IT WAS CONFIRMED THAT THE IMPLANT WAS FRACTURED AT THE HEX. THE IMPLANT WAS REMOVED AND A PUROS GRAFT WAS PLACED WITH MEMBRANE. A NEW IMPLANT WAS REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518114 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT A POST OP APPOINTMENT, BONE LOSS AND EXUDATE WERE NOTED AROUND THE IMPLANT AT TOOTH LOCATION #28. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 22577356 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 IMPLANTS PLACED FOR BAR OVERDENTURE. NO ISSUES FOR 4 MONTHS AND ONE BECAME INFECTED. INCISION DRAINAGE, IMPLANT WAS REMOVED. TOOTH SITE: 28. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22067163 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED POOR BONE DENSITY RESULTING IN FRACTURE OF LABIAL PLATE WHEN PLACING IMPLANT. THE SITE WAS GRAFTED AND PATIENT SENT HOME TO HEAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 13998850 ↗
• InjuryMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED RESULTING IN INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13861512 ↗