Tapered Screw-Vent® TSVM6B10Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00889024019676), received between Nov 14, 2019 and Jun 9, 2026 — classified as 52 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT PRESENTED FOR HYGIENE APPOINTMENT DURING THAT TIME PATIENT MENTIONED SOME DISCOMFORT BETWEEN CONTACTS OF RESTORATION. PROBING DEPTH OF 6 WAS NOTED. DOCTOR REMOVED RESTORATION AND IMPLANT WAS REMOVED AT THAT TIME. SYMPTOMS: PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 25448296 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 HAD LOST INTEGRATION AND BECAME MOBILE DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND BONE LOSS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 24057150 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS, SINUS PERFORATION AND FOR HAVING A LOOSE SCREW. THE PATIENT PRESENTED TO THE GENERAL DENTIST COMPLAINING THAT THE BRIDGE WAS LOOSE. THE GENERAL DENTIST NOTED THAT THE ABUTMENT SCREW AT SITE TOOTH SITE #5 HAD LOOSENED AND TISSUE HAD GROWN OVER THE IMPLANT AT THAT SITE. THE GENERAL DENTIST ALSO REPORTED THAT THE ABUTMENT SCREW ON THE IMPLANT AT SITE #3 HAD LOOSENED. DURING THE TORQUE ADJUSTMENT THE ABUTMENT BEGAN TO MOVE AND THAT THERE WAS EXUDATE FROM THE BUCCAL. THE OTHER IMPLANT THAT WAS CONNECTED TO THE BRIDGE WAS NOTED TO BE FINE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection

  MAUDE report 23975005 ↗
• InjuryDec 15, 2025Mechanical Problem; Mechanical Problem

  THE CUSTOMER RETURNED AN IMPLANT WITH NO SPECIFIC DETAILS. FOLLOW FOR ADDITIONAL INFORMATION WAS UNSUCCESSFUL. PRODUCT EVALUATION OF THE IMPLANT SHOWED A DAMAGED DRIVE FEATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801908 ↗
• InjuryDec 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE AREA WAS CLEANED OUT AND ANOTHER ZIMMER IMPLANT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND DISCOMFORT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23760473 ↗
• InjuryDec 3, 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; Unspecified Infection

  MAUDE report 23708722 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED INFECTION UPON THE EXAMINATION OF TOOTH SITE #14 AND TENDERNESS AT THE REGION. THE IMPLANT WAS REMOVED. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23369432 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. IMPLANT SITE WAS CLEANED AND GRAFTED. TOOTH # 3. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN, AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23328272 ↗
• InjuryAug 19, 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: Inflammation; Unspecified Infection

  MAUDE report 22842027 ↗
• InjuryJul 31, 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. BONE LOSS NOTED AT RECALL.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22677788 ↗
• InjuryJul 21, 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 PERIIMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. TOOTH #14. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22560096 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22331347 ↗
• InjuryMay 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 DUE TO THE GENERAL DENTIST HAVING OVER TORQUED IMPLANT. TOOTH SITE: 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030902 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD IMPLANT PLACED (B)(6) 2024. CAME IN 10/28/ FOR REGULAR FOLLOW UP. PATIENT EXPERIENCED SENSITIVITY. LET HEAL UNTIL (B)(6). STILL SENSITIVE. PRESCRIBED LEVAQUIN 500 FOR 7 DAYS. TOOTH SITE: 19.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21894382 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH #19. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND TENDERNESS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20182806 ↗
• InjuryAug 28, 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: Inflammation; Unspecified Infection; Zonular Dehiscence

  MAUDE report 20084507 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20037614 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20031910 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORAL SURGEON DRAINED THE INFECTION, REMOVED THE IMPLANT AND PLACED THE PATIENT ON AN ANTIBIOTIC. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, ASPIRATION, PAIN AND EDEMA.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 19991898 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTIST WAS TRYING TO TIGHTEN THE HEALING COLLAR AND PATIENT WAS HAVING PAIN DURING. PATIENT THEN CAME BACK HERE TO ORAL SURGEON AND WHEN WE TOOK THE X-RAY; THERE WAS OBVIOUS TRAUMA TO BONE AROUND IMPLANT AND IMPLANT ITSELF. HAD TO REMOVE IMPLANT DUE TO BONE LOSS, PUT NEW BONE GRAFT IN, ALLOGRAFT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 19908797 ↗
• InjuryApr 23, 2024Adverse 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.

  Patient problems: Osteolysis

  MAUDE report 19165883 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #13. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 19038996 ↗
• InjuryMar 21, 2024Fracture; Fracture

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18956185 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION ON TOOTH 31. IMPLANT WAS REMOVED FOR INFECTION. LOT NUMBER 1259400.

  Patient problems: Unspecified Infection

  MAUDE report 18560381 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH 3.

  Patient problems: Osteolysis

  MAUDE report 18164868 ↗