Tapered Screw-Vent® TSVB8Recalls & reported problems

Summary

The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 00889024019546), received between Jun 18, 2019 and Sep 29, 2026 — classified as 332 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 356 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a Peri-implantitis, tooth site 46.Patient suffered from inflammation and abscess.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50931940 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50651311 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant at tooth location 24 was removed due to a bone loss. Previously, during placement under the Z3D surgical guide protocol with no visual control of primary stability, the implant had rotated while unscrewing the Gentek scan cap.

  Patient problems: Osteolysis

  MAUDE report 50083422 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that implant at tooth site # 25 was removed due to a bone loss.

  Patient problems: Osteolysis

  MAUDE report 50034453 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 25447408 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25428669 ↗
• InjuryMay 27, 2026Adverse 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.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25302685 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25284840 ↗
• InjuryMay 14, 2026Adverse 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 25173918 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO INFECTION DURING SECOND STATE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25172411 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #44 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25172006 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #35 (FDI). THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25152824 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS WERE REMOVED FROM TOOTH SITE #3.6 - 3.7 DUE TO INFECTION. PATIENT SUFFERED PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25147137 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS WERE REMOVED FROM TOOTH SITE #3.6 - 3.7 DUE TO INFECTION. PATIENT SUFFERED PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25147126 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO A PERI-IMPLANTITIS AT TOOTH SITE #11. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. BONE TYPE: III.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25121459 ↗
• InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE 46. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE: III.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25121186 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25110099 ↗
• InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO A PERI-IMPLANTITIS. NO IMPACT ON THE PATIENT WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24919768 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EIGHTEEN (18) DAYS AFTER PLACEMENT, THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO INFECTION. THE PATIENT SUFFERED FROM PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24885798 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE GRAFT AND MEMBRANE PLACED AFTER IMPLANT REMOVAL.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24776644 ↗
• InjuryMar 30, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727142 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT CAME IN WITH SEVERE PAIN ON TOOTH #19. DOCTOR CHECKED HAD TO REMOVED IMPLANT DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24682606 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT CAME IN WITH SEVERE PAIN ON TOOTH #20. DOCTOR CHECKED HAD TO REMOVED IMPLANT DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24676976 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS PLACED AT TOOTH SITES #19 AND #20 ON (B)(6) 2024 WITH NONE GRAFTING AND PRP. ON (B)(6) 2024 IT WAS NOTED THAT THE SITES WERE HEALING WITHIN NORMAL LIMITS. ON (B)(6) 2025 NOTICEABLE BONE LOSS WAS NOTED, SO THE IMPLANT SURFACES WERE DEBRIDED AND GRAFTED. ON (B)(6) 2025 SIGNIFICANT BONE LOSS WAS NOTED AND IT WAS RECOMMENDED THAT THE IMPLANT BE REMOVED THAT DAY, BUT THE PATIENT DECLINED. THE PATIENT EXPRESSED THAT THEY EXPECTED TO RETURN IN APPROXIMATELY A WEEK. ON (B)(6) 2026 THE PATIENT RETURNED FOR AN IMPLANT REMOVAL. THEY WERE EXTREMELY LOOSE AND EASILY REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24569614 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS PLACED AT THE TOOTH SITES OF #19 AND #20 ON (B)(6) 2024 WITH NO GRAFTING AND PRP. IN AN EXAMINATION ON (B)(6) 2024, IT WAS NOTED THAT THE SITES WERE HEALING WITHIN NORMAL LIMITS. ON (B)(6) 2025, IT WAS OBSERVED THAT THERE WAS NOTICEABLE BONE LOSS. THE IMPLANT SURFACES WERE DEBRIDED AND THE BONE WAS GRAFTED AGAIN. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT BONE LOSS AND IMPLANT REMOVAL WAS RECOMMENDED THAT DAY, BUT THE PATIENT DECLINED. HE SAID HE WOULD RETURN IN APPROXIMATELY A WEEK. ON (B)(6) 2026 THE PATIENT RETURNED FOR IMPLANT REMOVAL AS THEY WERE EXTREMELY LOOSE AND EASILY REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24563576 ↗