Tapered Screw-Vent® TSVWH16Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024020122), received between Jul 2, 2020 and Dec 17, 2025 — classified as 19 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 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: Osteolysis

  MAUDE report 23830112 ↗
• InjuryDec 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 #24 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT WERE ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Erosion; Inflammation; Osteolysis

  MAUDE report 23797553 ↗
• InjuryDec 12, 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: Osteolysis

  MAUDE report 23794200 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN TOOTH SITES #24 & #25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED EDEMA, AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23547599 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN TOOTH SITES #32 AND #31 FAILED DUE TO INFECTION. THE DOCTOR REPORTED INFLAMMATION, EDEMA, AND THAT BOTH AUTOGENOUS AND HETEROLOGOUS GRAFTS WERE USED.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 23535874 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN TOOTH SITES #21 AND #31 FAILED DUE TO INFECTION. THE DOCTOR REPORTED INFLAMMATION, AND THAT BOTH AUTOGENOUS AND HETEROLOGOUS GRAFTS WERE USED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23535370 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN TOOTH SITES #21 AND #31 FAILED DUE TO INFECTION. THE DOCTOR REPORTED INFLAMMATION, AND THAT BOTH AUTOGENOUS AND HETEROLOGOUS GRAFTS WERE USED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23535239 ↗
• InjuryMay 23, 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 #3 AND #13 WERE REMOVED DUE TO BONE LOSS. FOLLOW UP ON (B)(6) 2025 TO RECONFIRM EVENT. PATIENT PRESENTED FOR UNCOVER OF TWO NEW IMPLANT AND THE TWO EXISTING IMPLANTS AT SITES 3 AND 13 WERE REMOVED DUE TO EXCESSIVE FACIAL BONE LOSS. NOTED OSTEOPOROSIS AND SJOGREN'S SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANTS WERE REMOVED GRAFTED: ALLOGRAFT PLACED PRIOR TO IMPLANT PLACEMENT.

  Patient problems: Osteolysis

  MAUDE report 22078430 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #7 AND 10 WERE INFECTED DUE TO MASSIVE DEFECT. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 20619693 ↗
• InjuryOct 1, 2024Adverse 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: Inflammation; Osteolysis; Pain

  MAUDE report 20343214 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC FOR MOBILE IMPLANT. AFTER EXAMINATION, ORAL SURGEON DECIDED IMPLANT NEEDED TO BE REMOVED DUE TO INFECTION, PERI-IMPLANTITIS, AND, BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19800607 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THEIR GENERAL DENTIST FOR A ROUTINE CHECK UP AND IT WAS NOTICED AT THAT TIME, THERE WAS SIGNIFICANT BONE LOSS AROUND IMPLANT AT TOOTH LOCATION # 11. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 18940543 ↗
• MalfunctionAug 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPRESSION COPING WILL ENGAGE WITH HEX OF IMPLANT. HOWEVER, THE PROSTHETIC SCREW AND IMPRESSION COPING SCREW WILL NOT FULLY ENGAGE. THREADS OF IMPLANT SEEM TO BE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191137 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DR. INDICATED BONE LOSS. TOOTH SITE # 3.

  Patient problems: Osteolysis

  MAUDE report 13539328 ↗
• InjuryNov 17, 2021Adverse 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 12829250 ↗
• InjuryJun 15, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wound Dehiscence

  MAUDE report 12005889 ↗
• InjuryJan 8, 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 A PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 11138783 ↗
• InjuryOct 23, 2020Adverse 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: Abscess; No Code Available; Pain; Unspecified Infection

  MAUDE report 10729560 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (TSVWH16) WAS REQUESTED TO BE REMOVED DUE TO PATIENT COMPLAINING OF CONSTANT INFLAMED GUM TISSUE AND PAIN AT TOOTH LOCATION 28.

  Patient problems: Inflammation; Pain

  MAUDE report 10379632 ↗
• InjuryJul 2, 2020Adverse 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 FROM SITE 5.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10227530 ↗