Tapered Screw-Vent® TSV4H13Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00889024019324), received between Oct 24, 2019 and Sep 8, 2026 — classified as 50 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported implant mobility due to bone loss. Tooth site 24.

  Patient problems: Osteolysis

  MAUDE report 50669323 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR DISCOMFORT AT THE IMPLANT OF TOOTH SITE #12. FOLLOWING CLINICAL EVALUATION, IT WAS DETERMINED THAT THE IMPLANT REQUIRED REMOVAL DUE TO PERI-IMPLANTITIS. THE IMPLANT IS EXPECTED TO BE REPLACED AFTER THE BONE GRAFT HEALS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24557821 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BONE LOSS AT THE FACIAL OF THE IMPLANT. LOSS OF STABILITY AT THE TIME OF TORQUE TEST APPOINTMENT. TOOTH SITE #22. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 23898060 ↗
• InjuryNov 6, 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 23486551 ↗
• InjuryOct 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 #27 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN, AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23406455 ↗
• InjurySep 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961050 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #37 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22951587 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 16 & 26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN, INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22951561 ↗
• InjuryAug 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 #4 WAS REMOVED IN ITS ENTIRETY DUE TO PERI-IMPLANTITIS. COPIOUS AMOUNTS OF GRANULATION TISSUE WERE REMOVED FROM THE BASE OF THE IMPLANT SITE WITH A CURRETTE. THIS SITE WAS COPIOUSLY IRRIGATED WITH CHLORHEXIDINE FOLLOWED BY NORMAL SALINE. PATIENT WAS GIVEN HYDROCODONE 5, IBUPROFEN 600, CHLORHEXIDINE AND PENICILLIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22906780 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANTIBIOTICS WERE PRESCRIBED TO TREAT INFECTION AND THE IMPLANT REMAINED IMPLANTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22859901 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANTIBIOTICS WERE PRESCRIBED TO TREAT INFECTION AND THE IMPLANT REMAINED IMPLANTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22859855 ↗
• InjuryAug 21, 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 #9 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22859544 ↗
• InjuryJun 19, 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 # (B)(6) WAS REMOVED DUE TO BONE LOSS AND INFECTION. CUSTOMER REPORTED PATIENT PRESENTED SCALING OR IMPLANT (B)(6), POSITIVE SUPPURATION AND SEVERE BONE LOSS, DEEP INTRA BONEY DEFECT CIRCUMFERENTIALLY AROUND IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22289184 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 31 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD DEEP POCKETS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22068157 ↗
• InjuryMar 11, 2025Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 21571080 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #7 AND 10 WERE INFECTED DUE TO MASSIVE DEFECT. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 20619692 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #32 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20210968 ↗
• InjuryJul 9, 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 #10 HAD BONE LOSS & INFECTION. PATIENT WAS PRESENT FOR EXAM, IMPLANT HAD 6MM AND 10MM PROBING DEPTHS AROUND IMPLANT AND SIGNIFICANT BONE LOSS. PATIENT HAD INFECTION AND DRAINAGE. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT , LET HEAL SINCE THERE WAS INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 19704578 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE IS INFECTION IN IMPLANT TOOTH SITE # UNKNOWN THEREFORE, IT IS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 19625294 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWED PERI-IMPLANTITIS AND BONE LOSS. REMOVED IMPLANT, DEBRIDED THE SITE AND BONE GRAFTED WITH ALLOGRAFT. TOOTH 5 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19622844 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO HER DENTIST WITH PAIN FROM THE IMPLANT. THE DENTIST NOTICED IT WAS LOOSE AND STARTED HER ON CLINDAMYCIN FOR INFECTION. TOOTH 5 (UNIVERSAL).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19622615 ↗
• InjuryFeb 1, 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. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, DRAINAGE. ADDITIONAL APPOINTMENT REQUIRED: YES, FOLLOW UP EVALUATION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18622352 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 24 AND 26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND SWELLING WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18328791 ↗
• InjuryOct 17, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 21 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17948200 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 25 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT. SITE WITH ALLOGRAFT

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17947849 ↗