Tapered Screw-Vent® TSVM6B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024019683), received between Jun 17, 2020 and Dec 22, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS NOTED TO HAVE BONE LOSS MID (B)(6) 2025; DURING ROUTINE RECALL APPT. AT SURGERY ON (B)(6) 2025, A 3 WALLED DEFECT, 10MM IN DEPTH WAS FOUND ON THE MESIAL OF THE IMPLANT. AFTER THOROUGH DEBRIDEMENT, IRRIGATION & DECONTAMINATION OF THE IMPLANT SURFACE. PUROS CANCELLOUS BONE ALLOGRAFT WAS CONDENSED INTO THE DEFECT AND A COPIOS EXTEND MEMBRANE PLACED OVER THE GRAFT. THE AREA WAS SUTURED AND PATIENT PLACED ON ANTIBIOTICS. POST OP PATIENT WAS DOING WELL. HE THEN PRESENTED TO HIS GENERAL DENTIST ON (B)(6) 2025; STATING THE CROWN WAS LOOSE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23871676 ↗
• MalfunctionNov 7, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501624 ↗
• InjuryAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED. IMPLANT FRACTURE AND RESTORATIVE FAILURE AS A RESULT. THE ABUTMENT AND CROWN WERE REMOVED AND A HEALING CAP WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 22891648 ↗
• InjuryJul 24, 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. NOTED BONE LOSS AND MOBILITY AT RECALL, TOOTH SITE: 30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22587803 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED BACK BY THE GENERAL DENTIST WITH EVIDENCE OF BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #3. PROBING DEPTHS OF ABOUT 9MM WERE PRESENT ON THE DIRECT BUCCAL AND PALATAL AND IMPLANT THREADS COULD BE FELT ALL ALONG THE DEPTH. THE SCREW-RETAINED CROWN DID NOT APPEAR TO BE TORQUED APPROPRIATELY AS THE SCREW WAS REMOVED FAIRLY EASILY. OCCLUSION WAS HIGH AS WELL. NO MOBILITY TO THE CROWN OR IMPLANT. A DEEP, NARROW INFRA-BONY DEFECT WAS FOUND ON THE BUCCAL WITH HORIZONTAL BONE LOSS ON THE PALATAL ASPECT. THE IMPLANT WAS UNSCREWED AND THEN THE SITE WAS GRAFTED WITH PUROS CANCELLOUS AND CORTICAL BONE AND COPIOS EXTEND MEMBRANE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22370620 ↗
• InjuryJun 16, 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 #2 AND #3 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22213309 ↗
• InjuryJun 16, 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 #2 AND #3 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22213220 ↗
• InjuryJan 31, 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: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21283170 ↗
• InjuryJan 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 #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21266833 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS GIVEN ANTIBIOTICS DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21148363 ↗
• InjuryJan 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 #30 WAS REMOVED DUE TO INFECTION. EXTRACTED TOOTH, PLACED PUROS AND COPIOS MEMBRANE AND PTFE SUTURES. HEALED WELL AND PLACED 6.0 TSV IMPLANT TO 45NM (B)(6) 2024. (ANTIBIOTICS, ORAL RINSE GIVEN AFTER EVERY BONE GRAFT AND/OR FIXTURE PLACEMENT) NO COMPLICATIONS. DEVELOPED BUCCAL SWELLING. WENT THOUGH ANOTHER DOSE OF ANTIBIOTICS. BACK IN WITH SWELLING. DECISION WAS MADE TO REMOVE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21148224 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON 10MM PROBING ON THE BUCCAL AROUND THE IMPLANT AT TOOTH LOCATION #14, PAIN WAS NOTED. THE IMPLANT WAS REMOVED WITH REVERSE TORQUE.

  Patient problems: Pain

  MAUDE report 19917661 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO INFECTION ON TOOTH SITE 31(UNIVERSAL). SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 19293692 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18999942 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT IMPLANT TOOTH SITE #30. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 17836849 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17625032 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP INDICATED THAT THE IMPLANT AT TOOTH LOCATION #12 GOT INFECTED AND NEEDED TO BE REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16906649 ↗
• MalfunctionJun 10, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THERE WAS A POSSIBLE MALFUNCTION WITH THE IMPLANT. IMPLANT WAS NOT GOING IN THE SITE. WE WERE NOT ABLE TO GET IMPLANT TO TORQUE INTO BONE. HOWEVER WE WERE ABLE TO GET DIFFERENT IMPLANT OF THE SAME SIZE TO GO IN. TOOTH #13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652851 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION. HOWEVER, BASED ON THE PLACEMENT AND REMOVAL DATES, THE IMPLANT WAS UNABLE TO BE PLACED. PATIENT WILL RETURN IN TWO MONTHS FOR A NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806534 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 30 WAS REMOVED DUE TO INFECTION. RADIOGRAPHS ARE AVAILABLE AT DR.'S OFFICE IF NEEDED. PATIENT TO RETURN FOR FUTURE RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10309654 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO THE LACK OF PRIMARY STABILITY. PATIENT WAS BONE GRAFTED AND SENT HOME FOR FUTURE IMPLANT PLACEMENT. TOOTH NUMBER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10162708 ↗