Tapered Screw-Vent® TSVMWB8Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00889024019812), received between Nov 27, 2019 and Sep 14, 2026 — classified as 100 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 111 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant became loose at tooth site 29 and was subsequently removed.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50751692 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 25279928 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. INFECTION ON EXAM #19, TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Unspecified Infection

  MAUDE report 25154121 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO AN INFECTION. AN ABSCESS WAS FOUND ON THE GUM, AND UPON OPENING, THE IMPLANT CAME OUT.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25042425 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION ON EXAM #30 #31 AND TENDERNESS AT THE REGION. NOTED INFLAMMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Unspecified Infection

  MAUDE report 25027529 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION ON EXAM #30 #31 AND TENDERNESS AT THE REGION. NOTED INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25027488 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 FAILED AND WAS REMOVED DUE TO BONE LOSS. THE PATIENT ALSO HAD A PERI-IMPLANT LESION AROUND THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Localized Skin Lesion; Osteolysis; Pain

  MAUDE report 24801405 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO BONE LOSS. PATIENT WAS SEEN ON (B)(6) 2026 FOR FOLLOW UP. NOTED SOFT TISSUE OPENING AND COVER SCREWS EXPOSED BUT NO COMPLAINTS. PATIENT SEEN ON (B)(6) 2026 FOR FOLLOW UP AND TISSUE HAD COMPLETELY CLOSED BUT WAS VERY INFLAMED AND EDEMATOUS. DECIDED TO OPEN FLAP AND CHECK IMPLANT. #29 PRESENTED BONE LOSS 2-3MM. DUE TO THE BONE LOSS DECIDED TO REMOVE THE REMAINING IMPLANT. REVERSED TORQUED WITHOUT DIFFICULTY. PATIENT WILL BE REFERRED TO MAXILLOFACIAL SURGEON FOR REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & EDEMA.

  Patient problems: Inflammation; Osteolysis; Swelling/ Edema

  MAUDE report 24758287 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO BONE LOSS. PATIENT WAS PRESCRIBED PAIN MEDICATION AND AMOXICILLIN 500MG AT IMPLANT PLACEMENT. PATIENT WAS SEEN ON (B)(6) 2026 FOR FOLLOW UP. NOTED SOFT TISSUE OPENING AND COVER SCREWS EXPOSED BUT NO COMPLAINTS. PATIENT SEEN ON (B)(6) 2026 FOR FOLLOW UP AND TISSUE HAD COMPLETELY CLOSED BUT WAS VERY INFLAMED AND EDEMATOUS. DECIDED TO OPEN FLAP AND CHECK IMPLANT. #31PRESENTED BONE LOSS 2-3MM AND HAVING A MESIAL SHALLOW CRATER. DUE TO THE BONE LOSS DECIDED TO REMOVE THE REMAINING IMPLANT. REVERSED TORQUED WITHOUT DIFFICULTY. PATIENT WILL BE REFERRED TO MAXILLOFACIAL SURGEON FOR REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & EDEMA

  Patient problems: Inflammation; Osteolysis; Swelling/ Edema

  MAUDE report 24758286 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION ON EXAM #30 AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24546410 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EARLY INFECTION AND THE DOCTOR CHOSE TO REMOVE THE IMPLANT AT TOOTH SITE #14. THE SITE WAS FLUSHED OUT AND ANTIBIOTICS WERE SENT TO THE PATIENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS; INFLAMMATION & PAIN

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 24443950 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24430597 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 LOST INTEGRATION AND WAS REMOVED DUE TO PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24086235 ↗
• InjuryDec 20, 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 #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT HAD CRESTAL BONE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23858664 ↗
• InjuryDec 11, 2025Fracture; Fracture

  DOCTOR REPORTED IMPLANT FRACTURE WHICH CAUSED LOOSE BRIDGE, AND THE IMPLANT WAS REMOVED. DOCTOR PERFORMED ABLATION AND CURETTAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776183 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERIIMPLANTITIS AROUND TOOTH SITE #14. IMPLANT WAS REMOVED. PATIENT REFERRED PAIN AND INFLAMMATION. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23736125 ↗
• InjuryNov 25, 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 #18 WAS REMOVED DUE TO INFECTION. TENDERNESS AT THE REGION WAS NOTED. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23648544 ↗
• InjuryNov 12, 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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. FAILED TORQUE TEST, TOO MOBILE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23532042 ↗
• InjuryNov 6, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23488057 ↗
• InjuryNov 6, 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: Unspecified Infection

  MAUDE report 23486822 ↗
• InjuryOct 24, 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. TOOTH SITE #26. PATIENT HAD ABSCESS, AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 23381425 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON EXAM, THERE WAS TENDERNESS AT THE REGION AROUND THE IMPLANT AT TOOTH SITE #12. INFECTION WAS NOTED AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Discomfort; Inflammation; Unspecified Infection

  MAUDE report 23042467 ↗
• InjuryJun 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. IMPLANT SHOWED EARLY SIGNS OF PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22324496 ↗
• InjuryJun 20, 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 #13, #14, AND #15 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22303262 ↗
• InjuryJun 20, 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 #3 AND #5 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22303120 ↗