Tapered Screw-Vent® TSVWB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 805 adverse event reports that list this exact device (DI 00889024020047), received between Sep 19, 2019 and Sep 29, 2026 — classified as 737 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Fracture” (95 reports).

3 other recalls cover devices cleared under the same FDA submission (K011028, K013227, K061410); they may or may not involve this specific model.

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Osteolysis

  MAUDE report 50934017 ↗
• MalfunctionSep 9, 2026Separation Failure

  It was reported the implant did not disengage the mount. The implant was removed and another implant was placed. No impact on the patient was reported. Restoration soft tissue graft performed. Tooth site 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691084 ↗
• MalfunctionSep 9, 2026Separation Failure

  Patient problems: Inflammation; Pain

  MAUDE report 50690962 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant was removed due to periimplantitis. The patient presents with irritation around the implant site.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50668172 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a loss of integration and a peri-implantitis. Tooth site 35.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50155126 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant at tooth site 14 was removed due to Bone Loss. Discovered during post op appointment. Grafted and will return in six months.Symptoms / Patient Impact: Abscess; Inflammation.

  Patient problems: Abscess; Inflammation; Osteolysis

  MAUDE report 50083793 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #26 AND #27 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25445321 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25414900 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED RAPID ONSET OF MOBILITY AROUND THE IMPLANT RESTORATION AT TOOTH SITE #14 FOLLOWING START OF ORAL BISPHOSPHONATE MEDICATION. CLINICAL EVALUATION CONFIRMED LOSS OF INTEGRATION DUE TO PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25355504 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25231519 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SWOLLEN AND IN PAIN. THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION WAS NOT PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Swelling/ Edema; Unspecified Infection

  MAUDE report 25216630 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25175614 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPACT ON THE PATIENT REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25175227 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #46. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25121399 ↗
• InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE 16. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE: III.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25121304 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUPPURATION ON BUCCAL PALPATION AROUND THE IMPLANT AT TOOTH SITE #36 AND THE IMPLANT WAS LOOSE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25092744 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE #32 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT PRESENTED INFLAMMATION IN THE SITE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25065527 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO A BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 25041501 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #14. IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED WITH OTHER IMPLANT. BONE TYPE: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25041073 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 37 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. BONE DENSITY TYPE: III.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25040990 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFLAMMATION, PAIN AND FEVER. AN X-RAY WAS TAKEN AND SIGNIFICANT INFECTION WAS EVIDENT AROUND THE IMPLANT AT TOOTH SITE #46 (FDI). THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION AND FEVER,

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 25033811 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 31 WAS REMOVED DUE TO PERI IMPLANTITIS. CLINICIAN STATED UNEVENTFUL POST OP COURSE. HEALING COLLAR PLACED ON (B)(6) 2025. PATIENT REPORTED EXFOLIATING GRAFT MATERIAL ON (B)(6) 2026. DURING RESTORATION OF IMPLANT 31 ON (B)(6) 2026, PATIENT REPORTED PAIN. UPON SURGICAL EXPLORATION, GRANULATED TISSUE WAS ASSOCIATED WITH THE IMPLANT CIRCUMFERENTIALLY AND IT WAS SLIGHTLY MOBILE. IMPLANT WAS REMOVED, SITE CURETTED, BONE GRAFTED. NOTED PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25019894 ↗
• InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO A PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT, DURING THE ONE-YEAR FOLLOW-UP AFTER PLACING THE SCREW-RETAINED PROSTHESIS ON THE IMPLANT, THE PROSTHESIS WAS REMOVED UNDER LOCAL ANESTHESIA TO CLEAN THE IMPLANT AND ASSESS THE SURROUNDING TISSUES. A SEVERE PERI-IMPLANTITIS WAS DETECTED, WHICH REQUIRED IMPLANT EXPLANTATION. PATIENT SUFFERED FROM DISCOMFORT.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24919764 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO BONE LOSS AND INFECTION. IMPLANT FAILED. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24899363 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. DURING DENTAL CLEANING, RADIOGRAPHS SHOWED BONE LOSS AT SITE 18.

  Patient problems: Osteolysis

  MAUDE report 24764606 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011028, K013227, K061410. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2017 · Jul 10, 2017 · Terminated
  ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
• Z-2144-2014 · Jul 17, 2014 · Terminated
  Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
• Z-0499-2010 · Nov 6, 2009 · Terminated
  Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.