Tapered Screw-Vent® TSV4H16Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024019331), received between Sep 27, 2020 and Nov 12, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN TOOTH SITES #32 AND #31 FAILED DUE TO INFECTION. THE DOCTOR REPORTED INFLAMMATION, EDEMA, AND THAT BOTH AUTOGENOUS AND HETEROLOGOUS GRAFTS WERE USED.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 23535705 ↗
• InjuryNov 23, 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 # 5 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 20766460 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO MEDICAL BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 15419210 ↗
• InjuryJul 1, 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, BONE LOSS, EDEMA, INFLAMMATION AND WOUND DEHISCENCE. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY TYPE OF NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 14889387 ↗
• InjuryJul 1, 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 IMPLANT SITE.

  Patient problems: Inflammation; Osteolysis; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 14884382 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH LOCATION #11 HAD LACK OF PRIMARY STABILITY AND NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

  Patient problems: No Code Available

  MAUDE report 11007912 ↗
• InjurySep 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 13 WAS UNABLE TO BE PLACE IN OSTEOTOMY AND WAS REMOVED. ATTEMPTED EXTRACTION WITH IMMEDIATE IMPLANT BUCCAL DEHISCENCE, DID GRAFT DELAY FOR HEALING NO TIME REPORTED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT DUE TO THE TIME THE IMPLANT WAS IN THE PATIENTS¿ MOUTH, IT IS DETERMINED THAT THE COMPLAINT CATEGORY REFLECTED AS UNABLE TO PLACE IN OSTEOTOMY.

  Patient problems: No Information

  MAUDE report 10591263 ↗