Tapered Screw-Vent® TSVT4B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00889024019867), received between Jan 2, 2020 and Sep 15, 2026 — classified as 126 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #12 was associated with pain and tenderness, first reported by the patient on (b)(6) 2026. At the follow-up appointment on (b)(6) 2026, peri-implantitis was suspected based on radiographic findings of radiolucency at the implant site.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50770071 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a routine reverse torque test to verify osseointegration prior to restoration. Infection was identified clinically and radiographically. The implant at tooth site 29 was removed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50755171 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. IMPLANT PLACED (B)(6) 2023 PATIENT EXT. (B)(6) 2023. IMPLANT LOADED (B)(6) 2024, BUT PATIENT RARELY WEARS PROSTHESIS, NO FOLLOW-UP WITH RESTORATIVE DENTIST UNTIL IMPLANT LOOSE (B)(6) 2026. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25174653 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 AND 31 HAD LOST INTEGRATION DUE TO PERIIMPLANTITIS AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION WITH BONE LOSS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24847340 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE IMPLANT AT TOOTH SITE #19 FELL OUT OVER THE WEEKEND. BONE LOSS WAS NOTED.

  Patient problems: Osteolysis

  MAUDE report 24621508 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE IMPLANT AT TOOTH SITE #29 WAS COMING OUT ON IT'S OWN. INFECTION WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 24327622 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #1 WAS REMOVED DUE TO INFECTION. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 24272146 ↗
• MalfunctionJan 20, 2026Component Missing

  IT WAS REPORTED THAT THE EMPTY IMPLANT VIAL WAS DISCOVERED WHILE GETTING READY TO DO AN IMPLANT PLACEMENT. THE PROCEDURE WAS ABLE TO BE COMPLETED AS THE DOCTOR HAD ADDITIONAL IMPLANTS. THE ROUND INNER VIAL WAS THERE INSIDE SQUARE SHAPE VIAL, BUT IT WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114852 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO INFECTION. THE PATIENT DEVELOPED RADIOGRAPHIC LUCENCY AT THE APEX OF THE IMPLANT. A BONE GRAFT WAS PLACED FOR RETREATMENT IN THE FUTURE. NEW BONE WAS NOTED TO BE FORMING AT THE TIME OF THE GRAFTING, AND THE IMPLANT REPLACEMENT IS ANTICIPATED IN (B)(6) 2026. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24073389 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISCOMFORT AROUND THE IMPLANT AT TOOTH SITE #19. THE PANOREX SHOWED BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED, A BONE GRAFT WAS PLACED AND A NEW IMPLANT WILL BE PLACED IN THE FUTURE. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24009057 ↗
• InjuryDec 31, 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 #20 WAS REMOVED DUE TO INFECTION. IMPLANT WAS PLACED AT SITE #21 ACCORDING TO ZIMMER DRILLING SEQUENCE PROTOCOL WITH COPIOUS IRRIGATION. IMPLANT WAS PLACED WITH PRIMARY STABILITY. WELL SEATED ON X-RAY IMAGING. NO GRAFTING WAS DONE AT THAT TIME. AN IMPLANT REPLACEMENT IS ANTICIPATED FOLLOWING A PERIOD OF SITE HEALING.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 23936922 ↗
• InjuryNov 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 #29 WAS REMOVED DUE TO BONE LOSS WHILE UNDER LOCAL ANESTHESIA. THE PATIENT PRESENTED WITH LOWER RIGHT PAIN. IT WAS NOTED THAT THE IMPLANT WAS MOBILE AND HAD BUCCAL BONE LOSS WITH AT LEAST EIGHT THREADS EXPOSED. IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE IMPLANT'S THREADS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23639014 ↗
• InjuryAug 23, 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 INFECTION. PATIENT HAD SWELLING, PAIN, AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 22880296 ↗
• InjuryJul 8, 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 PERI-IMPLANTITIS. PATIENT CAME WITH LOOSE CROWN, DISCOMFORT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22440013 ↗
• InjuryMay 27, 2025Adverse 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 AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, INFECTION BONE LOSS. TOOTH SITE: #20.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22090537 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO BONE LOSS INDICATED ON X-RAY. DOCTOR ALSO INDICATED SOFT TISSUE AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 22025703 ↗
• InjuryMay 7, 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 #4 WAS REMOVED DUE TO PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21979337 ↗
• InjuryApr 26, 2025Adverse 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. TOOTH SITE # UL3. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 21915373 ↗
• InjuryApr 17, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #35 FAILED BECAUSE IT FRACTURED AT THE HEAD AND WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854176 ↗
• InjuryMar 25, 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: Sinus Perforation

  MAUDE report 21686717 ↗
• MalfunctionMar 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577135 ↗
• MalfunctionMar 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577042 ↗
• InjuryMar 3, 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 #4, #6, #11, #13, #20, #22, #27 & #29 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21509633 ↗
• InjuryFeb 18, 2025Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO HAVING DAMAGED THREADS & LOSS OF OSTEOINTEGRATION. ADDITIONAL APPOINTMENT IS REQUIRED TO PLACE A NEW IMPLANT IN THE AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392871 ↗
• InjuryFeb 7, 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 #UNK WAS REMOVED DUE TO PERIIMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21332966 ↗