Tapered Screw-Vent® TSVM4H10Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024343993), received between Jun 12, 2020 and Mar 9, 2026 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550287 ↗
• InjuryNov 7, 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 #6 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23495772 ↗
• InjuryJul 24, 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 #11 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22587420 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANT FELL OUT OF THE MOUNT. WHEN REMOVING THE IMPLANT FROM THE CASE, IT FELL OUT OF THE MOUNT. THE DOCTOR COMMENTED THAT IT WAS LIKELY LOOSE FROM THE BEGINNING. THE DOCTOR SAID HE HAD SEEN SIMILAR CASES TWICE BEFORE. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506436 ↗
• InjuryMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712706 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #22 WAS INFECTED AND WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 21559960 ↗
• MalfunctionDec 2, 2024Separation Failure; Separation Failure

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819169 ↗
• InjuryOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE CROWN OFF OF THE IMPLANT AT TOOTH LOCATION #19. THE OUTSIDE COLLAR OF THE IMPLANT WAS NOTED TO BE FRACTURED. THE PATIENT WILL BE SEEN BY A PERIODONTIST FOR REMOVAL AND TO PLACE A NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 20464368 ↗
• InjuryApr 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING CLEANING, THE IMPLANT AT TOOTH LOCATION #4 WAS FOUND TO BE FRACTURED. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213827 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BECOME MOBILE AND WAS REMOVED DUE TO BONE LOSS. TOOTH #22 (UNIVERSAL).

  Patient problems: Osteolysis

  MAUDE report 19180372 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC TO CHECK IMPLANT MOBILITY AND PAIN AROUND THE IMPLANT AT TOOTH SITE #6. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18711034 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 13 WAS REMOVED DUE TO INFECTION. SITE WAS NOT GRAFTED, NO IMPACT TO PATIENT AND NO MEDICAL HISTORY REPORTED. SYMPTOMS: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15597594 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #2 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14981661 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATIONS #14 AND #15 WERE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14978486 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #29 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14978122 ↗
• MalfunctionFeb 24, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT DR. INDICATED DEVICE MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593876 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE #20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344615 ↗
• MalfunctionJun 12, 2020Separation Failure; Separation Failure

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

  Patient problems: No Information

  MAUDE report 10148646 ↗