Tapered Screw-Vent® TSV6H13Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024019478), received between Jul 10, 2020 and Jan 6, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT RETURNED TO OFFICE FOR IMPLANT CHECK AND COMPLAINED OF PAIN AND PRESSURE. RECOMMEND PATIENT RETURN FOR EVALUATION UNDER GENERAL ANESTHESIA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23981118 ↗
• InjuryOct 17, 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 BONE LOSS. DDS NOTED PUS FROM THE FACIAL ASPECT AT DENTAL CLEANING. BONE LOSS ESPECIALLY ON BUCCAL.

  Patient problems: Osteolysis

  MAUDE report 23325762 ↗
• 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 #19 WAS REMOVED DUE TO BONE LOSS & INFECTION. BONE LOSS ON EXAM AND PURULENT DRAINAGE SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PURULENT DRAINAGE.

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 22349893 ↗
• InjuryApr 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 #16 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21903185 ↗
• InjuryApr 17, 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

  MAUDE report 21860132 ↗
• InjuryMar 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO FRACTURE, WHICH WAS CONFIRMED WITH IMAGING. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652163 ↗
• InjuryOct 15, 2024Adverse 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. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 20455975 ↗
• InjuryOct 15, 2024Adverse 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 AND THE AREA WAS CLEANED.. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 20454403 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PT CALLED THE NEXT DAY AFTER IMPLANT PLACEMENT SAYING SHE WAS STILL VERY NUMB. GOT PT IN AND REMOVED IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA.

  Patient problems: Nerve Damage

  MAUDE report 20071492 ↗
• InjuryAug 22, 2024Adverse 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 20038591 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: DRAINAGE.

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 19731973 ↗
• InjuryApr 24, 2024Adverse 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 SUFFERED FROM BONE LOSS, 9MM PROBING DEPTHS. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 19172404 ↗
• InjuryNov 18, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166501 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18115943 ↗
• InjuryMay 5, 2022Adverse 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 WITH BONE LOSS. TOOTH #19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14289185 ↗
• InjuryJan 28, 2022Adverse 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 AT THE SITE. IMPLANT HAD TO BE TREPHINED OUT. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE. TOOTH #30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13385166 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 19 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12525992 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494565 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 12135954 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 30 WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE LOSS (MOAT DEFECT) 6 THREADS APICAL TO 1ST THREAD. PATIENT TO RETURN FOR IMPLANT RE-PLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: PERI-IMPLANTITIS, BONE LOSS, ABSCESS AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10256984 ↗