Tapered Screw-Vent® TSVTB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 512 adverse event reports that list this exact device (DI 00889024019928), received between Nov 27, 2019 and Sep 16, 2026 — classified as 490 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (50 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 29, 2017Class IITerminated

   Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

   Z-1189-2018 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 512 reports, in the reporter's own words as published by the FDA.

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

  It was reported that an implant was removed due to a bone loss at tooth site 29.Patient suffered from inflammation.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 50784153 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced numbness for a whole week, and therefore implants #29 and #31 were removed. Doctor reported nerve injury. Paresthesia and edema were also reported.

  Patient problems: Nerve Damage; Numbness; Paresthesia

  MAUDE report 50770689 ↗
• InjurySep 15, 2026Fracture

  It was reported that the patient went to the dentist office with the crown off the implant. The implant was found to be fractured and was therefore completely removed. Tooth site 29.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770272 ↗
• InjuryAug 18, 2026Fracture

  Patient was having an implant placed on #30 when doctor saw fracture at the top of implant #29.Implant at tooth site 30 was removed. New implant will be placed in 4 months.Patient had to have crown removed and implant removed with bone graft before a trip.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300871 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implant failed due to peri-implantitis. Pain was also reported.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50051498 ↗
• InjuryJul 27, 2026Operating System Becomes Nonfunctional

  It was reported the Implant at tooth site 8 became painful. Implant was removed due to bone loss.

  Patient problems: Osteolysis; Pain

  MAUDE report 50037033 ↗
• InjuryJun 10, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 FRACTURED AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461967 ↗
• InjuryJun 8, 2026Fracture

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE. ISSUED DISCOVERED BY PATIENT'S GENERAL DENTIST. IMPLANT WAS REMOVED. TOOTH NUMBER 30. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 25430744 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS NOTED TO BE INFECTED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25352155 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR UNCOVER OF THE IMPLANT AT TOOTH SITE #13 AND AT THAT TIME THE IMPLANT WAS DEEMED INTEGRATED AND READY TO RESTORE. THE PATIENT RETURNED WITH CONCERN OF SENSITIVITY AROUND THE IMPLANT, A LOOSE CROWN, AND A "BLISTER" ON THE GUM TISSUE NEAR THE IMPLANT. IT WAS DETERMINED AT THAT TIME THAT THE IMPLANT HAD FAILED AND REQUIRED REMOVAL DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25331326 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #34 AND #35 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25304815 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. DELAYED IMPLANT INFECTION STARTED FROM THE APEX OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25280808 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260737 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260697 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260676 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260625 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260611 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260560 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260540 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260500 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #18, #19, #20, #22, #27, #29, #30 & #31 BECAME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25260448 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 25174817 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25170618 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 IMPLANTS AT TOOTH SITES #23, 25 AND 26 WERE REMOVED DUE TO A BONE LOSS. OSSEOINTEGRATED IMPLANTS FOR 6 MONTHS THAT HAVE COMPLETELY RESORBED THE BUCCAL BONE PLATE. PROCEDURE WAS COMPLETED.

  Patient problems: Osteolysis

  MAUDE report 25109534 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 IMPLANTS AT TOOTH SITES #23, 25 AND 26 WERE REMOVED DUE TO A BONE LOSS. OSSEOINTEGRATED IMPLANTS FOR 6 MONTHS THAT HAVE COMPLETELY RESORBED THE BUCCAL BONE PLATE. PROCEDURE WAS COMPLETED.

  Patient problems: Osteolysis

  MAUDE report 25109279 ↗