Tapered Screw-Vent® TSVTWH8Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024344389), received between Aug 24, 2021 and May 27, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE PLACING THE IMPLANTS AT TOOTH SITES #30 AND #31, WHEN PLACING THE HEALING ABUTMENT, THE IMPLANTS WENT PAST THE CORTICAL PLATE CAUSING NERVE DAMAGE. THE IMPLANTS WERE REMOVED AND THE PATIENT NO LONGER WANTS IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PARASTHESIA.

  Patient problems: Inflammation; Nerve Damage; Paresthesia

  MAUDE report 25302202 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE PLACING THE IMPLANTS AT TOOTH SITES #30 AND #31, WHEN PLACING THE HEALING ABUTMENT, THE IMPLANTS WENT PAST THE CORTICAL PLATE CAUSING NERVE DAMAGE. THE IMPLANTS WERE REMOVED AND THE PATIENT NO LONGER WANTS IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PARASTHESIA.

  Patient problems: Inflammation; Nerve Damage; Paresthesia

  MAUDE report 25302134 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE TOOTH SITE WAS ANTICIPATED TO BE GRAFTED BACK FOUR MONTHS FROM THE IMPLANT REMOVAL DATE. AN APPOINTMENT WAS EXPECTED THREE MONTHS FROM THE TOOTH SITE REMOVAL DATE FOR A RE-EVALUATION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24462340 ↗
• InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Unspecified Infection

  MAUDE report 23388712 ↗
• InjuryJul 31, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 3 WAS REMOVED AS THE UNK TOOL FRACTURED IN THE IMPLANT & WOULD NOT DISENGAGE FROM IMPLANT. INSERTION PIECE BROKE INSIDE IMPLANT AND WAS COLD WELDED WAS UNABLE TO REMOVE AND FORCED TO DRILL PIECE OUT. INSTRUMENT WAS NOT FRACTURED DURING IMPLANT PLACEMENT. INSERTION PIECE FOR TSV IMPLANT BROKE. SPECIFICALLY THE TIP OF THE INSERTION PIECE. BECAUSE THE TIP OF THE INSERTION PIECE BROKE AND WAS COLD WELDED INTO THE IMPLANT. TLRT2 INSTRUMENT COULD NOT BE USED TO REMOVE PIECE AND FRACTURED PORTION OF INSERTION PIECE (OF IMPLANT) NEEDED TO BE DRILLED OUT. IMPLANT WAS REMOVED FROM PATIENT'S MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680086 ↗
• InjuryFeb 5, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT; PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21313766 ↗
• InjuryDec 23, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 30 FRACTURED AND LIKELY CAUSED CRESTAL BONE LOSS AND PAIN. PATIENT WILL NEED TO RETURN TO COMPLETE PROCEDURE. SITE WAS GRAFTED WITH ALLOGRAFT, PRIOR TO IMPLANT PLACEMENT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 20998921 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED LOSS OF BUCCAL BONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVAL ABX. ADDITIONAL APPOINTMENT REQUIRED: YES, RE-IMPLANT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO.

  Patient problems: Osteolysis

  MAUDE report 20577564 ↗
• InjuryAug 1, 2024Adverse 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: Erosion; Pain; Unspecified Infection

  MAUDE report 19884092 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT CAME IN WITH SWELLING AROUND IMPLANT # 19, IMPLANT HAD FAILED AND NEEDED TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 19839565 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #30 AND #31 WERE REMOVED DUE TO BONE LOSS & INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA & INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19732796 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CHANGED THEIR RESTORATIVE PLAN FOR THE IMPLANTS IN TOOTH SITES #13, #12 AND #3. DUE TO THIS, THE INITIAL IMPLANTS WERE REMOVED AND WILL NEED TO BE REPLACED IN A MORE IDEAL LOCATION FOR RESTORATIVE GOALS. THE IMPLANTS WERE REMOVED WITH NO COMPLICATIONS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion

  MAUDE report 19664815 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CLINICIAN THAT THE PATIENT HAD MOBILITY AND PAIN AT IMPLANT TOOTH SITE #30. THE PATIENT DEVELOPED AN ABSCESS INFECTION WITH BONE LOSS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17349958 ↗
• InjurySep 9, 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 #15 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 15393882 ↗
• InjuryJun 27, 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. COMPLETE ENCAPSULATION WITH TISSUE, OVER 1.5 YEARS AFTER CROWN DELIVERY. PAIN IS REPORTED AS A CONSEQUENCE. TOOTH SITE #3.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 14830490 ↗
• InjuryMar 9, 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 # 14 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13712413 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED LACK OF PRIMARY STABILITY DUE TO INSUFFICIENT BONE AT TOOTH SITE # 14. IMPLANT REMOVED AND AREA BONE GRAFTED. PATIENT RETURNING AFTER HEALING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870189 ↗
• InjuryAug 24, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE IMPLANT MIGRATED INTO THE MAXILLARY SINUS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION TOOTH LOCATION UNKNOWN.

  Patient problems: Inflammation; Pain

  MAUDE report 12360523 ↗