Tapered Screw-Vent® TSVM4B16Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024019652), received between Jul 2, 2020 and Jul 18, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 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 #10, #20 AND #22 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22546419 ↗
• InjuryJun 16, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22213341 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #19 WITH NEGATIVE PROGNOSIS AND FOOD ENTRAPMENT. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 19750681 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR 1 MONTH POST OP VISIT. PUS WAS FOUND. PATIENT IN PAIN. TOOTH #'14. DURING A FOLLOW UP EXAMINATION, SIGNS OF INFECTIONS WAS FOUND THAT INCLUDES PUS AND SWELLING. PROCEEDED WITH REMOVING THE IMPLANT.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19345481 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BONE LOSS AND INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #22. THE IMPLANT WAS REMOVED AND ANTIBIOTICS WERE PRESCRIBED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18502041 ↗
• InjuryNov 29, 2023Adverse 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. TOOTH SITE 12.

  Patient problems: Unspecified Infection

  MAUDE report 18233600 ↗
• InjuryAug 23, 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. TOOTH SITE # 27. INFLAMMATION IS REPORTED AS SYMPTOM.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15277164 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12631929 ↗
• InjuryJun 25, 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 LACKED OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066896 ↗
• InjuryDec 16, 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 FELT PAIN AND BONE LOSS. TOOTH LOCATION UNKNOWN.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 11018436 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY DOCTOR THAT EXTRACTION OF TEETH WITH IMMEDIATE IMPLANT PLACEMENT WAS BEING PERFORMED. PRIMARY STABILITY WAS NOT ACHIEVED WITH THE IMPLANT AT TOOTH LOCATION 12. AREA LEFT TO HEAL REGENEROSS CORTICOCANCELLOUS MIXED WITH OSSEOGUARD FLEX PLACED. THE IMPLANT PLACEMENT WILL BE AT LATER DATE.

  Patient problems: No Information

  MAUDE report 10227438 ↗