Tapered Screw-Vent® TSVTH10Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024344297), received between Aug 5, 2022 and Sep 30, 2026 — classified as 21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture

  Doctor reported the implant was removed due to a fracture. Tooth site 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946273 ↗
• InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23388743 ↗
• InjuryOct 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 #23 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23322757 ↗
• InjuryApr 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864790 ↗
• InjuryMar 13, 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 #5 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21595481 ↗
• MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733884 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #9 WAS REMOVED WITHOUT COMPLICATION DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20630283 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #8 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20200359 ↗
• InjuryAug 22, 2024Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026128 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #29 HAD AN INFECTION PRESENT, IMPLANT WAS REMOVED WITH NO COMPLICATIONS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19600519 ↗
• InjuryApr 1, 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 SUFFERED FROM BONE LOSS & INFECTION AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19015479 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATION #23 AND #25 WERE EASILY REMOVED WITH AN IMPLANT DRIVER DURING THE IMPLANT UN-COVERY PROCESS DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19006980 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS NOTED WHEN PATIENT CAME FOR 3 MONTH X-RAY. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. TOOTH SITE #4 (UNIVERSAL).

  Patient problems: Unspecified Infection

  MAUDE report 19003248 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PT. HAD IMPLANTS PLACED IN #'S 5, 8, 10, & 12 SITES FOLLOWING EXTRACTIONS (SAME DAY) ON (B)(6) 2023. DUE TO INFECTION #' 5 REMOVED DUE TO INFECTION ON (B)(6) 2023 SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18432769 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING EVALUATION FOR SITE 23 ONE MONTH FOLLOWING PLACEMENT NOTED BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN ABSCESS

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18137148 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING EVALUATION FOR SITE 26 ONE MONTH FOLLOWING PLACEMENT NOTED BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN ABSCESS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18127891 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT UNKNOWN SITE WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16362652 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REMOVED THE IMPLANTS DUE TO PERIMPLANTITIS. THE PATIENT IS TRANSFERRED FROM ANOTHER CLINIC. WHEN HEALING, BIOMET IMPLANTS WILL BE PLACED. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16142685 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS AND INFECTION WERE PRESENT AROUND THE IMPLANTS AT TOOTH LOCATIONS #23 AND #26 AT THE TIME OF UNCOVERY. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16139001 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS AND INFECTION WERE PRESENT AROUND THE IMPLANTS AT TOOTH LOCATIONS #23 AND #26 AT THE TIME OF UNCOVERY. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 16138991 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #19 AND #20 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFECTION, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 15175671 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH #19 AND #20 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: BONE LOSS, INFECTION AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 15175574 ↗