Tapered Screw-Vent® TSVM4H11Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024344006), received between Feb 12, 2021 and Apr 29, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANT AT TOOTH SITE #7 WAS UNCOVERED IN JANUARY. INFECTION WAS NOTICED AT THAT TIME. THE AREA AROUND THE IMPLANT WAS DEBRIDED AND THE PATIENT WAS PLACED ON ANTIBIOTICS. UPON REEVALUATION, THE IMPLANT HAD MORE BONE LOSS AND LOSS OF INTEGRATION. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25026947 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 DID NOT HEAL AND BONE DID NOT FILL IN AROUND THE IMPLANT. THERE WAS ACTIVE INFECTION PRIOR TO PLACEMENT THAT MAY HAVE BEEN THE CAUSING FACTOR. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 23523521 ↗
• InjuryJul 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT RETURNED TO CLINIC AFTER BEING EVALUATED BY MAY CLINIC AND RECENT SPECIALIZED TITANIUM TESTING WHICH CONFINES, HE'S ALLERGIC TO THE TITANIUM. TOOTH #'S 2, 23 AND 26. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, SENSITIVITY AND METALLIC TASTE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17327568 ↗
• InjuryJul 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17326563 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 20 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOM AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12619090 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Sinus Perforation

  MAUDE report 12480193 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 29.

  Patient problems: No Information

  MAUDE report 11321384 ↗