Tapered Screw-Vent® TSVWH8Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00889024020139), received between Feb 21, 2020 and Sep 7, 2026 — classified as 64 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50647167 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED PAIN, AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 23544846 ↗
• 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 #14 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis

  MAUDE report 23495717 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED LOSS OF INTEGRATION DUE TO PERI-IMPLANTITIS AT TOOTH SITES #13, #22, AND #24. IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23426285 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED LOSS OF INTEGRATION DUE TO PERI-IMPLANTITIS AT TOOTH SITES #13, #22, AND #24. IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23426138 ↗
• InjuryOct 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 #3, #6, #11 & #14 WERE REMOVED DUE TO BONE LOSS. PATIENT HAD ALL ON 4. PATIENT C/O PAIN UPPER R AND L AND FEELS LIKE PROSTHESIS IS LOOSE. AFTER EXAM FOUND POCKETING AROUND 4 IMPLANTS. ALL ARE MOBILE AND REMOVED. PLACED BONE GRAFT FOR POSSIBLE FUTURE IMPLANTS. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO, PLACED BONE GRAFTING FOR POSSIBLE FUTURE IMPLANTS. NEED TO DISCUSS TREATMENT PLAN WITH DDS AND RELEVANT PATIENT HISTORY. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23319474 ↗
• InjurySep 19, 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: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23095028 ↗
• InjuryJul 29, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND EDEMA.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22649881 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #46 & #47 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22466928 ↗
• InjuryMay 20, 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 #18 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22052618 ↗
• InjuryApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEX OF THE IMPLANT AT TOOTH SITE #19 WAS FRACTURED AND WAS THEREFORE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872293 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF NUMBNESS POST OP. THE IMPLANTS AT TOOTH SITES #18 & #19 WERE REMOVED DUE TO NERVE DAMAGE.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 21857357 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT FAILED DUE TO INFECTION. REMOVED IMPLANT ,TOOTH 19.

  Patient problems: Unspecified Infection

  MAUDE report 21604376 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21034321 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. PAINFUL EXAM, PATIENT PRESENTED W/PAIN DUE TO INFECTION OF #14 IMPLANT W/BONE LOSS. ZIMMER PRODUCTS WERE USED TO PLACE AND REMOVE IMPLANT. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACEMENT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20723399 ↗
• InjuryOct 1, 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: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20345253 ↗
• InjurySep 17, 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: Osteolysis

  MAUDE report 20239885 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20210933 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AREA #19 HAS BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19773229 ↗
• InjuryJul 18, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771351 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON EXAM, IMPLANT WAS NOTED TO HAVE MILD DRAINAGE. X-RAYS TAKEN SHOWED BONE LOSS AROUND IMPLANT. TOOTH #19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA AND INFLAMMATION.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 19762288 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #30. 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 19751190 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain

  MAUDE report 19629869 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT ALSO HAD FISTULA ON THE BUCCAL OF THE IMPLANT.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 19447626 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TWO MONTHS POST IMPLANT PLACEMENT WITH CONTINUED INFLAMMATION AND GINGIVAL SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #3. DEBRIDEMENT AROUND THE AREA WAS ADMINISTERED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19230787 ↗