Tapered Screw-Vent® TSVWH10Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00889024020092), received between Nov 20, 2019 and Sep 18, 2026 — classified as 170 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 25 most recent of 182 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Fracture; Separation Failure

  It was reported that the implant neck fractured after the transfer hex component became stuck. The fractured component was successfully removed, however, due to dense bone and mobility, it was not possible to engage the 1.25 mm hex driver. The implant could not be removed by standard methods, and implant removal and replacement is recommended. Procedure not completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816722 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient came in with abscess and pocket around implant. Had to be removed due to peri-implantitis. Tooth site 14.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50264134 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25027091 ↗
• MalfunctionMar 16, 2026Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606271 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24496954 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24209399 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS HURTING AND THE PATIENT PUSHED IT OUT WITH THEIR TONGUE. THE PATIENT BROUGHT THE IMPLANT INTO THE OFFICE. THE IMPLANT CAME OUT DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24209207 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 23959912 ↗
• InjuryDec 15, 2025Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS REMOVED DUE TO A FRACTURE AND A DAMAGED HEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803866 ↗
• InjuryDec 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 SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. PT HAD INFLAMMATION AND FOOD TRAP THAT EVENTUALLY CAUSED BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION, PAIN & SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23772297 ↗
• InjuryNov 11, 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. PERI-IMPLANTITIS NOTED. RECOMMEND SECTION BRIDGE DISTAL #20 AND REMOVE IMPLANT #18. PLAN PLACE NEW IMPLANT IN #19 AS SINGLE IMPLANT CROWN RATHER THAN REPLACING BRIDGE. NEW IMPLANT PLACED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23522361 ↗
• InjuryOct 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 #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: FISTULA, BUCCAL AND APICAL BONE LOSS. PAIN AND INFLAMMATION.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 23418178 ↗
• InjuryOct 27, 2025Device Damaged by Another Device; Device Damaged by Another Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388910 ↗
• 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 23319455 ↗
• 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 23319426 ↗
• InjuryAug 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

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

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

  MAUDE report 22769897 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. CUSTOMER REPORTED BONE LOSS AND INFECTION. PATIENT COMPLAINING OF PAIN AROUND IMPLANT SITE. IMPLANT FOUND TO BE MOBILE, TOOTH 4.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22686974 ↗
• InjuryJul 12, 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 #18 WAS REMOVED DUE TO SEVERE BONE LOSS. THE PATIENT CLAIMED PROBLEMS WITH BALANCE WHICH THEY ASSOCIATED WITH THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22488877 ↗
• InjuryJul 11, 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 #30 WAS TREATED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: FISTULA.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 22482776 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #47 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22477333 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BRIDGE AT TOOTH SITES #12 AND #14 CAME OUT. IT WAS NOTED THAT THE PATIENT HAD BEEN VERY SICK FOR SEVERAL YEARS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22476290 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BRIDGE AT TOOTH SITES #12 AND #14 CAME OUT. IT WAS NOTED THAT THE PATIENT HAD BEEN VERY SICK FOR SEVERAL YEARS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22476256 ↗
• 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 22466834 ↗
• InjuryJul 9, 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 WAS REMOVED DUE TO CHRONIC INFECTION. DEBRIDEMENT WAS DONE ON REMOVAL DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA AND INFLAMMATION.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 22456702 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS 5MM BONE LOSS AROUND THE CREST OF THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 22370785 ↗