Tapered Screw-Vent® TSVWB13Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 00889024020061), received between Nov 7, 2019 and Sep 10, 2026 — classified as 168 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 177 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with a superior bridge at tooth #13 and that the implant abutment had fallen out (avulsed) due to Periimplantits

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50714169 ↗
• InjuryAug 26, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported the patient had an implant placement on (b)(4) 2023. A follow-up examination revealed an abscess on the alveolar ridge crest at the implant site; probing detected a periodontal pocket, and CBCT imaging showed a radiolucent area surrounding the implant. A diagnosis of peri-implantitis was made, and the implant was removed on the same day. Tooth site 25.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50452079 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25300675 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25285995 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 25278438 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THE AREA OF TOOTH SITE #7 AND WAS REMOVED DUE TO BONE LOSS. THE SITE WAS GRAFTED IN ANTICIPATION OF A REPLACEMENT IMPLANT PROCEDURE IN APPROXIMATELY THREE MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis

  MAUDE report 24809192 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #9 AND #11 WERE REMOVED AS THE IMPLANTS WERE NOT IN A POSITION FOR PROPOSED IMPLANT SUPPORTED FULL DENTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779580 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS PLACED BY A DOCTOR. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 24746821 ↗
• MalfunctionMar 20, 2026Unsealed Device Packaging

  DOCTOR REPORTED THAT PACKAGING WAS OPEN (LOSS OF STERILITY). ANOTHER STERILE IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647067 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24323269 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 23961097 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO CRESTAL BONE LOSS, THE IMPLANTS AT TOOTH SITES #5 AND #6 HAD TO BE REMOVED AND REPLACED.

  Patient problems: Osteolysis

  MAUDE report 23750651 ↗
• InjuryDec 1, 2025Adverse 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: Pain; Unspecified Infection

  MAUDE report 23689525 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 47 AND # 46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23586782 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 47 AND # 46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23586719 ↗
• MalfunctionNov 3, 2025Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448690 ↗
• InjuryOct 27, 2025Adverse 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 23392499 ↗
• InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BONE LOSS AND INFECTION IN TOOTH SITE # 25. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22880258 ↗
• InjuryJul 15, 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 INFECTION. THE DOCTOR FOLLOWED THE TSV SURGICAL PROCEDURES TO PLACE THE IMPLANT - TSVWB13. AFTER 3 WEEKS, INFECTION WAS HAPPENED TO THE PATIENT. TOOTH SITE # 37. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22506319 ↗
• InjuryJun 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 16 OBSERVED DURING THE CLINICAL PROCEDURE AND THE IMPLANT WAS REMOVED. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22208218 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 21983940 ↗
• InjuryApr 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO PERI-IMPLANTITIS, FROM INFECTION. TOOTH # 8. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21915360 ↗
• InjuryMar 17, 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 #16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21618989 ↗
• InjuryMar 6, 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 INFECTION. IN (B)(6) 2022, THE PATIENT WENT TO THE DOCTOR DUE TO THE MISSING UPPER RIGHT 7 AND UPPER LEFT 7. AFTER EXAMINATION, IMPLANTS OF 4.7*13 WAS IMPLANTED. THE INITIAL STABILITY IS GOOD. TWO AND A HALF YEARS AFTER IMPLANTATION, IT WAS FOUND THAT LOCAL INFECTION, REDNESS AND SWELLING AROUND THE IMPLANT, AND THE IMPLANT WAS LOOSENED AND REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 21535103 ↗
• InjuryJan 15, 2025Adverse 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: Swelling/ Edema; Unspecified Infection

  MAUDE report 21161732 ↗