Tapered Screw-Vent® TSVTWH13Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024344365), received between Jul 16, 2020 and Jan 16, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24099666 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24099603 ↗
• InjuryAug 26, 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 #30 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20067879 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND LOSS OF BUCCAL PLATE AND CRESTAL BONE. THE PATIENT HAD EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #11, WITH ASSOCIATED ABSCESS, INFLAMMATION, AND PAIN. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17966407 ↗
• MalfunctionJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANT WAS RECEIVED WITH THE MOUNT UNATTACHED. THE CLINICIAN REATTACHED THE MOUNT TO THE IMPLANT AND ATTEMPTED TO PLACE THE IMPLANT. WHILE TRANSPORTING IMPLANT TO THE PATIENT'S MOUTH THE IMPLANT FELL TO THE FLOOR FROM MOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250732 ↗
• MalfunctionAug 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT THAT THE FIXTURE MOUNT COPING SCREW FRACTURED IN THE MOUNT. THE SCREW AND MOUNT ARE BUNDLED WITH THE IMPLANT THAT REMAINS IMPLANTED WITH NO REPORTED DAMAGE. TOOTH LOCATION #22. DURING PRODUCT INSPECTION OF THE RETURNED DEVICES, A FRACTURED MOUNT WAS IDENTIFIED. THERE WAS NO DAMAGE TO THE RETURNED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351374 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (TSVTWH13 ) WAS UNABLE TO BE PLACED. IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 5. SITE WAS BONE GRAFTED.

  Patient problems: No Information

  MAUDE report 10285680 ↗