Tapered Screw-Vent® TSVT4B16Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024019850), received between Mar 17, 2020 and Feb 5, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24271999 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #33 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22113172 ↗
• InjuryMar 14, 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 14 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18903104 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH LOCATION 11.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17874299 ↗
• InjuryMar 8, 2023Adverse 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. SYMPTOMS: PAIN, SWELLING AND INFLAMMATION. TOOTH SITE 11 (UNIVERSAL).

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

  MAUDE report 16501338 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT BELIEVES SHE HAS CALCIUM BUILDUP IN HER ARTERIES DUE TO IMPLANTS. TOOTH #4. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT. IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372146 ↗
• InjuryOct 5, 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 PERI-IMPLANTITIS AT THE SITE WITH AN ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 15546702 ↗
• InjuryDec 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: Pain; Unspecified Infection

  MAUDE report 12973429 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726888 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 12673636 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT EXTRACTION AND IMMEDIATE PLACEMENT. PATIENT HAS HISTORY OF OSTEOPOROSIS WITH EXTREMELY SOFT BONE. ATTEMPTED SIZE AT SITE #4, BONE GRAFT PLACED, PATIENT RETURNING AFTER HEALING FOR FUTURE IMPLANT PLACEMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12633002 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT TIME OF IMPLANT PLACEMENT, PATIENT BIT DOWN ON HANDPIECE CAUSING A LACK OF PRIMARY STABILITY AND A BONE FRACTURE. PATIENT WILL RETURN FOR ANEW IMPLANT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12406895 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372572 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS LACK OF PRIMARY STABILITY AT AN UNKNOWN TOOTH LOCATION. THE IMPLANT WAS REMOVED AND THE AREA WAS GRAFTED. PATIENT IS RETURNING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370598 ↗
• InjuryJul 13, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12161540 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TSVT4B16 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION IS ALSO REPORTED AS A CONSEQUENCE. TOOTH SITE # 9 (UNIVERSAL). SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL PLACEMENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 11889270 ↗
• InjuryApr 8, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633216 ↗
• MalfunctionJan 21, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Information

  MAUDE report 11210631 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED. COULD NOT ENGAGE IMPLANT TO THE CORRECT TORQUE. THERE WAS AN ISSUE WITH LACK OF INITIAL STABILITY WITH TORQUE LESS THAN 15 NM. ALSO, NO THERE WAS NO DAMAGE OF BONE DURING THE IMPLANT REMOVAL. IT WAS SIMPLY IMMEDIATE IMPLANT PLACEMENTS WITH INITIAL BONE LOSS. THE SITES WERE GRAFTED WITH PLANNED IMPLANT PLACEMENTS IN 3 MONTH. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: No Information

  MAUDE report 11031738 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION. PATIENT ALSO HAD INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9937870 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR COULD NOT GET PRIMARY STABILITY WHEN PLACING THE DENTAL IMPLANT. THE SITE WAS BONE GRAFTED AND THE PATIENT IS SET TO RETURN IN 3 TO 4 MONTHS FOR IMPLANT PLACEMENT.

  Patient problems: No Information

  MAUDE report 9843502 ↗