Tapered Screw-Vent® TSVWB16Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024020078), received between Feb 21, 2020 and Apr 16, 2026 — classified as 34 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS. THE IMPLANT HAD FAILED, WAS REMOVED AND A BONE GRAFT WAS PLACED. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24905144 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 23842701 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22750926 ↗
• InjuryMay 29, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED, UPDATING THE REPORTED EVENT. BASED ON THE ADDITIONAL INFORMATION IT WAS CONFIRMED THAT THE IMPLANT DEVICE HAD NOT FRACTURED, BUT THAT THE IMPLANT TOOTH SITE SUFFERED BONE LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 22108574 ↗
• InjuryFeb 24, 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 AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21446479 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT 6 IMPLANTS HAVE BEEN PLACED IN 2020. SLIGHT BONE LOSS AROUND THE IMPLANT 33 AND WAS REMOVED DUE TO PERI IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20559010 ↗
• InjurySep 10, 2024Adverse 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 INFECTION AND BONE LOSS. PAIN, EDEMA, INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT. NEW APPOINTMENT REQUIRED TO PLACE A DIFFERENT IMPLANT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20178590 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS (BONE LOSS WITH LOCALIZED SOFT TISSUE INFECTION.) TOOTH NUMBER #20. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20053334 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18978205 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE 36 WERE REMOVED DUE TO PERI-IMPLANTITIS. DISCOVERED DURING RESTORATION. PATIENT WILL RETURN AFTER 4 MONTHS TO PLACE A NEW IMPLANT

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18978086 ↗
• InjuryOct 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #45 WAS REMOVED DUE TO INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17982040 ↗
• InjuryJul 26, 2023Adverse 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 AN INFECTION. THE IMPLANT WITH ABUTMENT WERE REMOVED, AND SITE GRAFTED FOR FUTURE PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 17397908 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT #5 (UNIVERSAL) WAS REMOVED, DUE TO BONE LOSS AND SITE BONE GRAFTED. PAIN IS REPORTED AS A CONSEQUENCE. THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 16094423 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #8 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15304564 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #6 WAS EXTRACTED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 14605461 ↗
• InjuryApr 15, 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 AN INFECTION WITH A FISTULA AND PAIN.

  Patient problems: Fistula; Pain; Unspecified Infection

  MAUDE report 14119608 ↗
• InjuryApr 8, 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 MEDICAL INFECTION AND BONE LOSS.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14050786 ↗
• InjuryFeb 24, 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 AND INFECTION. INFLAMMATION WAS NOT REPORTED. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #30.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 13590396 ↗
• InjuryApr 22, 2021Adverse 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 CHRONIC INFECTION PATIENT DECIDED NOT TO HAVE IMPLANTS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11706607 ↗
• InjuryApr 22, 2021Adverse 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 CHRONIC INFECTION PATIENT DECIDED NOT TO HAVE IMPLANTS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11706566 ↗
• InjuryApr 22, 2021Adverse 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 CHRONIC INFECTION PATIENT DECIDED NOT TO HAVE IMPLANTS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11706506 ↗
• InjuryApr 19, 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 #14 WAS REMOVED DUE TO INFECTION. PATIENT DEVELOPED INFECTION, REGRAFTED, PLACED PATIENT ON ANTIBIOTIC, REMOVED IMPLANT. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED

  Patient problems: Unspecified Infection

  MAUDE report 11690714 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11649560 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11645620 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11645582 ↗