Tapered Screw-Vent® TSV6B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00889024019393), received between Nov 20, 2019 and Feb 13, 2026 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO SIGNIFICANT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24333348 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COVER SCREW CAME OFF THE IMPLANT AT TOOTH SITE #5. X-RAY IMAGING CONFIRMED LOSS OF INTEGRATION, IMPLANT MOBILITY AND AN ACTIVE INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE AND ALTERNATE THE IMPLANT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 23881476 ↗
• InjuryDec 13, 2025Adverse 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: Osteolysis

  MAUDE report 23797833 ↗
• InjuryOct 21, 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 #3, #30 AND #31 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23349284 ↗
• InjuryAug 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO FRACTURE. THE PATIENT EXPERIENCED A BROKEN IMPLANT CROWN WHILE EATING A SANDWICH AND PRESENTED FOR AN EMERGENT PROCEDURE. THE IMPLANT WAS REMOVED WITH A TREPHINE BUR AND THE SITE WAS REGRAFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772108 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN WENT TO TIGHTEN THE HEALING CAP ON THE IMPLANT AND THE IMPLANT WAS SPINNING. IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19588470 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #34 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19531281 ↗
• MalfunctionJun 11, 2024Separation Failure; Separation Failure

  DOCTOR REPORTED IT IS IMPOSSIBLE TO UNSCREW THE MOUNT FROM THE IMPLANT. DOCTOR CONFIRMED PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509584 ↗
• InjuryMar 28, 2024Adverse 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: Pain; Swelling/ Edema

  MAUDE report 18993751 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17842310 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT AN UNKNOWN IMPLANT, WITH ASSOCIATED INFLAMMATION. THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17834204 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA, AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16428823 ↗
• InjuryApr 29, 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 PERI-IMPLANTITIS. PAIN AND MOBILITY WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 14249784 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PLACED INTO AN IMMEDIATE EXTRACTION SITE WAS UNABLE TO ACHIEVE STABILITY. IMPLANT REMOVED AND AREA GRAFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13000596 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PLACED INTO AN IMMEDIATE EXTRACTION SITE # 3. UNABLE TO ACHIEVE 1% STABILITY. IMPLANT REMOVED AND AREA GRAFTED. PATIENT RETURNING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982659 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO UNABLE TO PLACE. UNABLE TO ACHIEVE FIRST STABILITY. NO SYMPTOMS WAS REPORTED. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972760 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT PLACED INTO AN IMMEDIATE EXTRACTION SITE # 14. UNABLE TO ACHIEVE 1% STABILITY. IMPLANT REMOVED AND AREA GRAFTED. PATIENT RETURNING FOR FUTURE IMPLANT PLACEMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962207 ↗
• MalfunctionOct 22, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682340 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACE DUE TO LACK OF PRIMARY STABILITY. PATIENT RETURNING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286537 ↗
• InjuryApr 21, 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 #30 WAS UNABLE TO ACHIEVE STABILITY AND WAS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11701004 ↗
• InjuryJan 13, 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 #6 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY. EXTRACTED #6 ON (B)(6) 2020. TRIED TO PLACE IMPLANT BUT THE SOCKET WAS TOO LARGE. WILL LET BONE HEAL 7 WEEKS THEN REPLACE IMPLANT. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT REPORTED ADDITIONAL APPOINTMENT REQUIRED: YES, FUTURE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: NONE.

  Patient problems: No Information

  MAUDE report 11165602 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THETSV6B13 IMPLANT HAD TO BE REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH SITE # 19. PAIN IS ALSO REPORTED AS SYMPTOM.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10952147 ↗
• InjuryDec 3, 2020Adverse 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: Abscess; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10942715 ↗
• InjuryJul 17, 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 INFECTION, ABSCESS IN TOOTH SITE # 14.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 10290027 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT DURING PLACEMENT OF IMPLANT TSV6B13, PRIMARY STABILITY WAS NOT ACHIEVED. ANOTHER IMPLANT WAS NOT SUCCESSFULLY PLACED. TOOTH SITE #30.

  Patient problems: No Information

  MAUDE report 9350702 ↗