Tapered Screw-Vent® TSVB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 892 adverse event reports that list this exact device (DI 00889024019508), received between Aug 20, 2019 and Sep 29, 2026 — classified as 829 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Fracture” (117 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 10, 2018Terminated

   Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

   Z-2963-2018 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 892 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50931058 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50931020 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50930965 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50930913 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to an infection and a bone loss at tooth site 14. Patient suffered from pain, edema and abscess

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 50912341 ↗
• InjurySep 18, 2026Fracture

  It was reported that the patient presented to the office with issues with his crowns not staying. Upon evaluation, implant fracture was found and implant was removed, tooth site 20. Bone graft placed to fix defect from implant placement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817426 ↗
• InjuryAug 16, 2026Fracture

  It was reported that the collar of implant has a crack at tooth site 4. Implant was removed due to fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50264402 ↗
• InjuryAug 6, 2026Fracture

  It was reported that the implant at tooth #19 fractured and was removed. Failed implant removed and another implant placed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155711 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, at the 18-month follow-up, the implant at Tooth Site 24 exhibited deep probing depths and soft tissue irritation. The patient was unable to wear the locator overdenture attachment. The implant was subsequently removed due to peri-implantitis. Pain and inflammation were also reported.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50054129 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BONE DID NOT TAKE AROUND THE IMPLANT AT TOOTH SITE #7. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25414462 ↗
• InjuryJun 4, 2026Fracture

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO A FRACTURE AT THE IMPLANT COLLAR. PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388937 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO BONE LOSS. ADDITIONAL APPOINTMENT REQUIRED TO REPLACE IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 25355702 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 25355445 ↗
• MalfunctionMay 29, 2026Component Missing

  IT WAS REPORTED THAT NO IMPLANT WAS FOUND IN THE INNER PACKAGE. PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25327977 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25321980 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25303037 ↗
• InjuryMay 27, 2026Component Missing

  IT WAS REPORTED THAT THERE WAS NO IMPLANT IN THE VIAL, IT WAS SEALED. DISCOVERED DURING A SURGERY, BUT THEY WERE ABLE TO USE ANOTHER IMPLANT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303036 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT A TOOTH SITE #23 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25230475 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION AND PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 25185175 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 23 & 24 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED BY PLACING OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25175299 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR FOLLOWED THE TSV SURGICAL PROCEDURES TO PLACE THE IMPLANT AT TOOTH SITE #15 (PALMER). AFTER THREE (3) WEEKS, INFECTION OCCURRED AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25125469 ↗
• InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE: III.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25121012 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 FAILED AT STAGE 2 AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25111003 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 12 15 36 17 43 AND 45 FAILED DUE TO PERI-IMPLANTITIS. PROTHESIS WAS MOBILE DUE TO PERI-IMPLANTITIS, AND WHEN DOCTOR TRIED TO REMOVE THE PROTHESIS, THE IMPLANTS CAME OUT. THE DOCTOR REPORTS IN THE FORM THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25012530 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 16 & 27 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24979688 ↗