Tapered Screw-Vent® TSVTWB16Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024020023), received between Aug 20, 2019 and Jun 8, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT SELF REFERRED TO US STATING THE IMPLANT WAS VERY LOOSE AND PAINFUL. WE REMOVED THE IMPLANT THAT SAME DAY. TOOTH NUMBER 3.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25431873 ↗
• InjuryDec 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 23831207 ↗
• InjuryApr 30, 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

  MAUDE report 21932984 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21 & 28 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21932947 ↗
• InjuryFeb 4, 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; Pain; Unspecified Infection

  MAUDE report 21304659 ↗
• InjuryFeb 4, 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; Pain; Unspecified Infection

  MAUDE report 21304182 ↗
• InjuryFeb 22, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED BONE LOSS, PERI-IMPLANTITIS AND STRIPPED INTERNAL THREADS AROUND THE IMPLANT AT TOOTH LOCATION #6.THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18759519 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNS FOR EXPOSURE OF IMPLANT #6. CRESTAL INCISION AND FT FLAP TO EXPOSE. PURULENT DISCHARGE UPON INCISION. FLAP REFLECTED, MODERATE BONE LOSS ON BUCCAL AND MESIAL OF FIXTURE. IMPLANT REMOVED WITH REVERSE TORQUE. GRAFTING WITH PUROS. CLOSED WITH 4-0 GUT SUTURE. PATIENT TO RETURN IN 3 MONTHS FOR NEW X-RAY AND REPLACEMENT OF IMPLANT. ADDITIONAL APPOINTMENT REQUIRED: PATIENT WILL RETURN TO HAVE IMPLANT REPLACED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16198627 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERI-IMPLANTITIS WAS NOTED AROUND THE IMPLANT AT TOOTH LOCATION #13 WITH MORE THAN 50% BONE LOSS AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, EDEMA, INFLAMMATION.

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

  MAUDE report 15796905 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #6 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15770602 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21 AND #28 WERE REMOVED DUE TO INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15761176 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT AT TOOTH LOCATION #27 WAS REMOVED DUE TO BONE LOSS. THE PATIENT WILL RETURN FOR A NEW IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 12696968 ↗
• InjurySep 24, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527382 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 11837833 ↗
• InjuryMay 17, 2021Adverse 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: Unspecified Infection

  MAUDE report 11833037 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT WAS A SPINNER; IT LACKED OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 28.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822104 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TSVTWB16 FOR TOOTH # 28 UNABLE TO PLACE IN OSTEOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395531 ↗
• InjuryJan 15, 2021Fracture

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Information

  MAUDE report 11180578 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 28 WAS REMOVED DUE TO INFECTION. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10203248 ↗
• InjuryJun 26, 2020Adverse 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.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10202450 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE # 5 COULD NOT BE PLACED DUE TO INADEQUATE BONE / STABILITY. THE IMPLANT WAS REMOVED AND BONE GRAFT PLACED. PATIENT TO RETURN FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Information

  MAUDE report 9850051 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT (TSVTWB16) AT TOOTH LOCATION #13 WAS UNABLE TO BE PLACED INTO THE OSTEOTOMY DUE TO PERFORATION OF THE SINUS FLOOR.

  Patient problems: No Information

  MAUDE report 8911231 ↗