Tapered Screw-Vent® TSVTB16Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00889024019959), received between Dec 5, 2019 and Apr 21, 2026 — classified as 43 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A HEALING CHECK WITH SUTURE REMOVAL AND BONE LOSS WAS NOTED AROUND THE IMPLANTS AT TOOTH SITES #23 AND #26. THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24944514 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A HEALING CHECK WITH SUTURE REMOVAL AND BONE LOSS WAS NOTED AROUND THE IMPLANTS AT TOOTH SITES #23 AND #26. THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24944382 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO SEVERE BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. THE IMPLANT WAS REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24552512 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS OUT OF THE COUNTRY FOR MANY MONTHS AFTER IMPLANT PLACEMENT AT TOOTH SITE #9. THE PATIENT HAD A SCREW-RETAINED TEMPORARY OVER OF OCCLUSION AND HAD PAIN IN (B)(6) 2025. THE PATIENT RETURNED FOR TREATMENT A FEW DAYS LATER AND THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23559996 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED, THERE WAS SIGNIFICANT BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED. TOOTH SITE IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 22921018 ↗
• InjuryJul 14, 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 #26 HAD BEEN HAVING UNDISCLOSED PROBLEMS WITH THE IMPLANT SINCE THE BEGINNING. X-RAY IMAGING WAS UNREMARKABLE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE PATIENT CONFIRMED IMPROVEMENT. SHORTLY AFTER, THE PATIENT REPORTED THAT THE IMPLANT HAD FALLEN OUT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Erosion; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22494207 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH THE GUMS SWOLLEN UNDER THE TONGUE. THE PATIENT HAS BEEN HAVING PROBLEMS SINCE IMPLANT PLACEMENT AT TOOTH SITE #26. THE PATIENT WAS PLACED ON ANTIBIOTICS AND STEROIDS. RX: AUGMENTIN 875 D.14. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22484571 ↗
• InjuryMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 FRACTURED AND IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528910 ↗
• InjuryNov 6, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20620802 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 21 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20357701 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20340877 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LARGE BONE LOSS WAS DISCOVERED AND IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 20315288 ↗
• MalfunctionAug 7, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT AT THE MOMENT OF THE SURGERY, IT WAS FOUND THAT THE VIAL WAS EMPTY; IMPLANT MISSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931868 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 16 & 23 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: II. THE DOCTOR REPORTED : INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19195878 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT IMPLANT TOOTH SITE #7, WITH ASSOCIATED ABSCESS, PAIN AND INFLAMMATION. PATIENT STARTED TO SWELL AND GET INFLAMMATION/INFECTION ONE WEEK FOLLOWING THE IMPLANT PLACEMENT. THEY HAD TO REMOVE THE IMPLANT AND GRAFT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18956249 ↗
• MalfunctionMar 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #12 WAS INTERNALLY DAMAGED DURING CLINICAL PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915448 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING TREMENDOUS PAIN SINCE THE IMPLANT AT TOOTH LOCATION #9 HAD BEEN PLACED. THE IMPLANT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 18437659 ↗
• InjuryJul 14, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323078 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WITH SORENESS, SWELLING AND INFLAMMATION AROUND THE IMPLANT TOOTH SITE #23; THEREFORE, THE IMPLANT WAS DECIDED TO BE REMOVED.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17133309 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17120243 ↗
• InjuryMay 11, 2023Adverse 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: Osteolysis

  MAUDE report 16916198 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #16 WERE REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Abscess; Erosion; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16567266 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16368643 ↗
• InjuryJan 25, 2023Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239977 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN ON THE IMPLANT AT TOOTH LOCATION #7. A LESION WAS FOUND AT THE TIP OF IMPLANT. THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

  Patient problems: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15812245 ↗