Tapered Screw-Vent® TSVT6B10Recalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 00889024019874), received between Jan 15, 2020 and Sep 7, 2026 — classified as 191 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 199 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50646691 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site 14 was removed due to periimplantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50081083 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RETAINING SCREW AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. PATIENT RETURNED TO OFFICE IN SEVERE DISCOMFORT. TISSUES INFLAMED AROUND IMPLANT. INFECTION PRESENT, PATIENT DID NOT WANT TO TAKE ANTIBIOTICS. IMPLANT WAS REMOVED.SYMPTOMS: PAIN AND INFLAMMATION, DISCOMFORT.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 25414724 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN AN UNKNOWN TOOTH SITE HAD MOBILITY IN THE CROWN AND IMPLANT. ACUTE BONE LOSS AND PERIODONTAL DISEASE WAS NOTED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL RETURN IN THE FUTURE FOR REPLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24912623 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. THE SITE WAS ALLOWED TO HEAL IN ANTICIPATION OF AN IMPLANT REPLACEMENT APPROXIMATELY THREE MONTHS FROM THE IMPLANT REMOVAL DATE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24377005 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SWELLING WITH NUMBNESS UNDER THEIR CHIN. THE IMPLANT AT TOOTH SITE #30 WAS REMOVED. PATIENT TO FOLLOW-UP IN APPROXIMATELY THREE OR FOUR MONTHS TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24338990 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS. THE BONE SITE WAS GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24028373 ↗
• InjuryJan 5, 2026Fracture

  IT WAS REPORTED IMPLANT #19 FRACTURED AT THE COLLAR AND WAS REMOVED. IMPLANT WAS DISCARDED AND WILL NOT BE RETURNING. SITE 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968186 ↗
• InjuryDec 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 #18 WAS REMOVED DUE TO ADVANCED BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. THE TOOTH SITE WAS GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23917731 ↗
• InjuryDec 20, 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 #3 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23858549 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED INFLAMMATION AND MINIMAL INFECTION TWO (2) MONTHS AFTER IMPLANT PLACEMENT AT TOOTH SITE #14. POST TISSUE HAD HEALED BUT A SMALL FISTULA PERSISTED. OVERTIME, THE IMPLANT LOST MORE SUPPORTING BONE AND THE CLINICIAN DECIDED TO REMOVE THE IMPLANT DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23850816 ↗
• InjuryDec 5, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS AND DEEP POCKET. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23733103 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE HAD DAMAGED THREADS. THE CUSTOMER CONFIRMED THAT THIS WAS NOTED PRIOR TO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648948 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE IMPLANT RELEASE APPOINTMENT, 3-4 MICRO THREADS WERE VISIBLE AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND THE SITE ENCOUNTERED PURULENT DRAINAGE. DUE TO THE PRESENCE OF INFECTION, THE SITE WAS GRAFTED AND CLOSED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 23605801 ↗
• InjuryNov 16, 2025Fracture; Fracture

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

  Patient problems: Erosion; Inflammation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565683 ↗
• InjuryNov 14, 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; Pain

  MAUDE report 23559781 ↗
• InjuryNov 11, 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 #3 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23526083 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT TAKEN INFECTION AROUND IMPLANT #19, PATIENT IN PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23344521 ↗
• InjuryAug 27, 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 # 21 & # 19 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Bruxism; Osteolysis

  MAUDE report 22907345 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE, WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WAS INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22823806 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO OUR OFFICE FOR DISCUSSION OF IMPLANT PLACEMENT ON THE UPPER LEFT AND PAIN WITH THE EXISTING IMPLANT ON THE UPPER RIGHT. THE IMPLANT ON UPPER RIGHT AT TOOTH SITE #3 HAD FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22680007 ↗
• InjuryJun 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT PRESENTED WITH ABSCESS ON THE BUCCAL OF THE IMPLANT; THREADS OF IMPLANT WERE EXPOSED AND REMOVAL OF THE IMPLANT WAS RECOMMENDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22366937 ↗
• InjuryJun 27, 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 #31 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22347530 ↗
• InjuryJun 23, 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; Unspecified Infection

  MAUDE report 22312518 ↗
• InjuryJun 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 #18 WAS REMOVED DUE TO INFECTION. THE PATIENT NOTICED A WHITE BUMP ON THE GUM TISSUE; THEN THE WHITE BUMP TURNED RED AND WAS TENDER TO THE TOUCH. THE BUMP WAS ON THE BUCCAL SIDE OF THE MOUTH.

  Patient problems: Unspecified Infection

  MAUDE report 22309113 ↗