Tapered Screw-Vent® TSV6H11Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024019461), received between Apr 16, 2021 and Nov 10, 2025 — classified as 28 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 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 WAS REFERRED BY DDS DUE TO BONE LOSS AROUND IMPLANT. SIGNIFICANT BONE LOSS ON DISTAL ASPECT, RECOMMEND DEBRIDEMENT. DEBRIDED IMPLANT AND PLACED BONE AND MEMBRANE. 3 MO POST OP DEBRIDEMENT, PATIENT STATES NO MOBILITY OR DISCOMFORT. NOW SWELLING OR INFECTION. 4MM PROBING DEPTH ON DISTAL. BONE LOSS STILL PRESENT WITH NO IMPROVEMENT. RECOMMEND REMOVAL. REMOVED IMPLANT. COPIOUS AMOUNTS OF GRANULATION TISSUE DEBRIDED AND PLACED GRAFT. BONE GRAFT HEALED WELL. PLAN: ANOTHER IMPLANT. PATIENT HAS NOT YET RETURNED

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23513600 ↗
• InjuryOct 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23417033 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #14 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22025751 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PROBING DEPTHS OF 12MM ON THE BUCCAL ASPECT OF THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21942042 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR EXAM AT THE REQUEST OF THEIR DDS. THE PATIENT HAD SOME SWELLING AND A BAD TASTE THAT STARTED 2 WEEKS PRIOR TO THE EXAM. THE IMPLANT REMAINED IMPLANTED AND THE DDS GAVE THE PATIENT ANTIBIOTICS (KEFLEX) AT THAT TIME. PERI-IMPLANTITIS WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21941694 ↗
• InjuryApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO FRACTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 21917632 ↗
• InjuryApr 21, 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21872424 ↗
• InjuryApr 8, 2025Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 21800902 ↗
• InjuryApr 8, 2025Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 21800802 ↗
• InjuryMar 18, 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 PAIN. IMPLANT PLACED AND PATIENT RETURNED 4 DAYS LATER WITH PAIN AND TINGLING. PATIENT HAS SOME SENSATION INTRA AND EXTRA ORALLY. DISCUSSED WITH PATIENT THAT COULD JUST BE FROM INFLAMMATION COMPRESSING ON THE NERVE. DISCUSSED LEAVING THE IMPLANT FOR A FEW DAYS TO SEE IF THERE IS ANY IMPROVEMENT. PATIENT CHOSE TO REMOVE IMPLANT DUE TO PAIN. REMOVED IMPLANT AND PLACED PUROS GRAFT. UPON REMOVAL, NOTED THERE WAS A BONY FLOOR AND INFERIOR ALVEOLAR NERVE WAS NOT EXPOSED. PATIENT HAS NOT RETURNED FOR IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 21631454 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANTIBIOTIC (CLEOCIN) WAS PRESCRIBED TO THE PATIENT FOR 15 DAYS BEFORE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21610671 ↗
• InjuryMar 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 #31 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21577289 ↗
• InjuryJun 19, 2024Adverse 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 WITH PAIN & PUSS IN IMPLANT AREA.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 19570568 ↗
• InjuryJun 18, 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 PERI-IMPLANTITIS. BONE GRAFT PLACED AT TIME OF REMOVAL FOR PLAN OF ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19559298 ↗
• InjuryJun 17, 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 # UNKNOWN WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD BONE LOSS BUT IMPLANT WAS STILL SOLID. DEBRIDEMENT OF IMPLANT AND FOUND CEMENT DEBRIS ON BUCCAL ASPECT OF IMPLANT. 3-4 MM OF BONE LOSS. PLACED PUROS AND MEMBRANE AT TIME OF DEBRIDEMENT. AT 3 MONTH CHECK AFTER DEBRIDEMENT, PATIENT HAD PUS AND BONE LOSS WAS STILL PRESENT. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19553754 ↗
• InjuryJun 4, 2024Fracture; Unintended Movement; Fracture; Unintended Movement

  THE SUPPLEMENTAL MW, 0002023141-2024-01846-1 FOR THE LOOSENED SCREW WAS SUBMITTED INCORRECTLY UNDER THE IMPLANT AS A CORRECTION. THIS EVENT IS FOR THE FRACTURED IMPLANT ONLY. A NEW COMPLAINT, (B)(4) WAS CREATED TO SUBMIT THE SCREW CORRECTLY.

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

  MAUDE report 19460863 ↗
• InjuryMay 24, 2024Fracture; Fracture

  IT WAS REPORTED BY THE RESTORATIVE DENTIST THAT IMPLANT AT TOOTH #19 FRACTURED AT THE COLLAR. PATIENT IS SCHEDULED FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396527 ↗
• InjuryMay 13, 2024Fracture; Fracture

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

  Patient problems: Inflammation; Pain

  MAUDE report 19299318 ↗
• InjuryApr 29, 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 #18 SUFFERED FROM INFECTION. PATIENT HAD SWELLING IN FLOOR OF MOUTH/NECK, PAIN SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19202958 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #18 & #31 SUFFERED FROM BONE LOSS AND HAD TO BE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 19173868 ↗
• InjuryJul 26, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402070 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND PAIN AT TOOTH #14; THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16983767 ↗
• InjuryMay 12, 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 16918901 ↗
• InjuryApr 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN X-RAY TAKEN AT THE GENERAL DENTIST SHOWED DISTAL BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #19. PROBING BLEEDING WAS NOTED AT THE CONSULT, OTHERWISE THE TISSUE WAS PINK AND WAS CHECKED FOR CONTAMINATION. BONE LOSS WAS TOO EXTENSIVE, AND THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16792689 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #31 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 14800462 ↗