Tapered Screw-Vent® TSVT4B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 00889024019836), received between Oct 25, 2019 and Jun 9, 2026 — classified as 249 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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 265 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25449039 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION FORMED AROUND THE IMPLANT.AT TOOTH SITE #12. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25323093 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT SITE BECAME INFECTED AND FAILED TO INTEGRATE. THE SITE WILL BE ALLOWED TO HEAL TRADITIONALLY AND AN IMPLANT PLACEMENT WILL BE ATTEMPTED AGAIN IN APPROXIMATELY TWO TO THREE MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25019283 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. DOCTOR PERFORMED BONE REGENERATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25012901 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24597192 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. ON (B)(6) 2025, THE PATIENT PRESENTED FOR AN EMERGENCY VISIT COMPLAINING OF SOURNESS AROUND THE IMPLANT. PAX IMAGING CONFIRMED 2-3 MM OF VERTICAL BONE LOSS AND SIGNS OF PERI-IMPLANTITIS. THIS CASE IS A REFERRAL. PROGNOSIS IS POOR.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24570784 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 24524103 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND SUPPURATION NOTED AT OFFICE VISIT. REMOVAL OF IMPLANT WITH BONE GRAFT PLACEMENT COMPLETED, FUTURE EVALUATION FOR IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24520715 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO INFECTION. PATIENT CAME BACK WITH PAIN, REMOVED IMPLANT, SIGNS OF INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24199775 ↗
• InjuryJan 26, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO A FRACTURE AT THE NECK PORTION OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184396 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24117742 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT BECAME INFECTED FAILING TO INTEGRATE, WILL ALLOW SITE TO HEAL TRADITIONALLY AND RE-ATTEMPT IN 2-3 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24066329 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT REPORTED SWELLING AND PAIN AT TOOTH SITE #22. THE IMPLANT HAD TO BE REMOVED; INFECTION WAS PRESENT AS WELL. SITE WAS CURETTED. A NEW IMPLANT WAS NOT INDICATED AT THE TIME. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24060257 ↗
• InjuryDec 30, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. IT WAS REPORTED THAT THE PATIENT WAS STARTING TO HAVE PAIN WITH THE IMPLANT. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED APPROXIMATELY THREE MONTHS FROM THE DATE OF THE IMPLANT REMOVAL FOR A GRAFT CHECK AND OR IMPLANT REPLACEMENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23927918 ↗
• InjuryDec 17, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23829461 ↗
• InjuryDec 11, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT BOTH IMPLANTS HAD TO BE REMOVED DUE TO AN ALLERGIC REACTION AND INFECTION. THE DOCTOR WILL NOW WAIT FOR REGENERATION. PAIN WAS REPORTED AS A RESULT OF THE EVENT. AFFECTED DENTAL POSITIONS: UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 23778430 ↗
• InjuryDec 11, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT BOTH IMPLANTS HAD TO BE REMOVED DUE TO AN ALLERGIC REACTION AND INFECTION. THE DOCTOR WILL NOW WAIT FOR REGENERATION. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 23778349 ↗
• InjuryDec 1, 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 #14 WAS REMOVED DUE TO BONE LOSS. AT STAGE 2 IMPLANT UNCOVERING SURGERY, DISTAL PALATAL BONE LOSS DISCOVERED. REMOVED IMPLANT AND RE-GRAFTED. DID NOT REPLACE WITH NEW IMPLANT AT THIS TIME DUE TO BONE LOSS. IMPLANT REMOVED AND GRAFTED, PATIENT WILL HAVE TO RETURN TO CARE FOR PLACEMENT OF NEW IMPLANT

  Patient problems: Osteolysis

  MAUDE report 23689504 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUPRAGINGIVAL PLAQUE AND OR CALCULUS FORMATION AT THE TOOTH SITES OF #28 AND #29. POOR ORAL HYGIENE WAS NOTED. THE IMPLANTS AT TOOTH SITES #28 AND #29 WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND DISCOMFORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23689077 ↗
• InjuryOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 HAD FRACTURED AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438012 ↗
• InjuryOct 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263947 ↗
• InjurySep 19, 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, #5, #7, #9, AND #13 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23100132 ↗
• InjuryAug 29, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN, AND GUM INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22924085 ↗
• InjuryAug 28, 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 #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22911015 ↗
• InjuryAug 26, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANT WAS PLACED AT TOOTH SITE #6. POST-OPERATIONAL WAS NOTED TO BE UNEVENTFUL. A HEALING ABUTMENT WAS PLACED AND THE IMPLANT WAS TORQUED TO 30 N-CM. THE IMPLANT HAD THE HEX REMOVED, BUT THE ENCODE WOULD NOT DISENGAGE. THE SCREW HAD FUSED WITH THE IMPLANT COPING. THE PATIENT THEN BEGAN TO EXPERIENCE DISCOMFORT. TWO HOURS LATER THE IMPLANT WAS FOUND TO BE LOOSE. A NEW IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 22894670 ↗