Tapered Screw-Vent® TSVMB16Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024019751), received between Mar 18, 2021 and Jul 21, 2025 — classified as 17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. TOOTH #12. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22559887 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #10, #20 AND #22 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22546336 ↗
• InjuryJun 22, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22304583 ↗
• InjuryJun 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7 AND #10 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22303786 ↗
• InjuryJun 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7 AND #10 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22303728 ↗
• InjuryJun 17, 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 #27 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WAS REMOVED, SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22228976 ↗
• InjuryMay 8, 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 #27 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21989436 ↗
• InjurySep 10, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181068 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION ON EXAM IN TOOTH SITE AREA #7 AND TENDERNESS IN THE REGION. THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20033428 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION ON EXAM #13 AND TENDERNESS AT THE REGION. INFLAMMATION. THE IMPLANT WAS REMOVED. THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 16355760 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) AND (B)(4) ARE CASES FOR THE SAME PATIENT. THIS (B)(4) CAPTURED LEFT SIDE EVENT. IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR LEFT SIDE OA WITH THE LINER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED ON (B)(6) 2023, THE LINER HAS BEEN WORN OUT DUE TO AGING. A REVISION SURGERY IS PLANNED SOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 16239711 ↗
• InjurySep 1, 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 BONE LOSS. TOOTH SITE #22 (UNIVERSAL).

  Patient problems: Osteolysis

  MAUDE report 15337352 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR ADVISED OF BONE/JAW FRACTURE AT IMPLANT AREA #15. PATENT ADVISED THAT THE BONE/ FRACTURE IS A RESULT OF CHEWING/TORQUE OF DENTAL IMPLANT. PATIENT AGREES TO SURGICAL EXTRACTION OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: SENSITIVITY AND PAIN.

  Patient problems: Bone Fracture(s); Pain; Sensitivity of Teeth

  MAUDE report 14799911 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. CUSTOMER DIDN'T USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. ABSCESS WAS REPORTED. PATIENT WONT RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH# 4.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 13178446 ↗
• InjuryDec 20, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Discomfort; Headache

  MAUDE report 13042079 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO INFECTION. INFECTION ON EXAM #4 TENDERNESS AT THE EXAM. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NONE. ADDITIONAL APPOINTMENT REQUIRED: YES. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12367423 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR'S OFFICE REPORTED INFECTION. IMPLANT WAS REMOVED. PATIENT RETURNING FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION. TOOTH LOCATION NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 11516767 ↗