Tapered Screw-Vent® TSVT6B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00889024019898), received between Apr 1, 2020 and Apr 29, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN, SWELLING, AND DRAINAGE FROM THE IMPLANT AT TOOTH SITE # (B)(6). THE SITE WAS OPENED AND THE AREA SHOWED MAJOR BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND THE AREA WAS GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25035654 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22283936 ↗
• InjuryMay 30, 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 NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22113258 ↗
• MalfunctionJan 22, 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 21210976 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED AND BONE GRAFTING WAS PERFORMED. TOOTH 19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19260282 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 7. PER THE GENERAL DDS, THE PATIENT EXPERIENCED PERI-IMPLANTITIS, TISSUE INFLAMED WITH EXUDATE. DUE TO BONE LOSS, THE IMPLANT WAS REMOVED AND THE SITE WAS RE-GRAFTED WITH RIDGE AUGMENTATION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19034373 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 6. PER THE GENERAL DDS, THE PATIENT IS STILL HAVING TENDERNESS ALL THE TIME. RECOMMENDED POCKET REDUCTION. THE IMPLANT REMAINED IMPLANTED. POCKET REDUCTION WAS DONE.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19034153 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 5. PER THE GENERAL DDS, THE PATIENT IS STILL HAVING ISSUES. CBCT SHOWS BONE LOSS ON BUCCAL AND WRAPPING INTERPROXIMAL. ANOTHER TIP OF ARESTIN WAS PLACED. THE IMPLANT REMAINED IMPLANTED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 19033776 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 4. PER THE GENERAL DDS, THE PATIENT WAS STILL HAVING DISCOMFORT WITH THE IMPLANT WITH 7MM POCKETS SURROUNDING THE IMPLANT. THE PATIENT WAS PRESCRIBED PERDEX TO USE ON TEPE BRUSHES TO CLEAN THE AREA. THE IMPLANT REMAINED IMPLANTED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 19032515 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 3. PER THE GENERAL DDS, POCKET REDUCTION WAS DONE WITH LASER TREATMENT (ND YAG (WAIVE LENGTH LASER)). THE IMPLANT REMAINED IMPLANTED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19031884 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 2. PER THE GENERAL DDS, THE PATIENT EXPERIENCED ANOTHER 6MM POCKET SYMPTOMS AT THE APEX OF THE IMPLANT. THE IMPLANT REMAINED IMPLANTED AND RESTING WAS PLACED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19031219 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE EVENTS WERE REPORTED FOR THIS PATIENT IN AN EFFORT TO TREAT/RESOLVE ISSUES ASSOCIATED WITH PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19 PRIOR TO IMPLANT REMOVAL. THIS REPORT IS FOR EVENT 1. PER THE GENERAL DDS, THE PATIENT EXPERIENCED ADVANCED INFLAMMATION AND 9MM POCKET SYMPTOMS AT THE APEX OF THE IMPLANT. THE IMPLANT REMAINED IMPLANTED AND ARESTIN WAS PLACED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19030986 ↗
• InjuryMar 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #13, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18823231 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANTS' TOOTH SITES #3 AND 4. THE IMPLANT AT SITE #3 FELL OUT ON PATIENT AT HOME DUE TO BONE LOSS. FOR IMPLANT AT SITE #4 GRAFTING WAS GOING TO BE ATTEMPTED; HOWEVER, ONCE THE AREA WAS OPEN, IMPLANT AT SITE #4 WAS DEEMED FAILED AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17873846 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT OVER THE LAST FEW DAYS SWELLING OCCURRED BETWEEN SITES #14 AND #15 AND ALSO HAVE SMALL AMOUNTS OF PUSS. THE PATIENT IS FRUSTRATED AND HESITANT TO REMOVE THE IMPLANT. THE CLINICIAN ADVISED THAT THE CONDITION IS NOT IMPROVING ENOUGH TO KEEP THE IMPLANT AND RECOMMENDED AT LEAST TO EXPLORE AND PERFORM DEBRIDEMENT. THE PATIENT WAS OK WITH THAT BUT ONCE THE IMPLANT WAS EXPOSED, IT WAS NOTABLY MOBILE AND INFECTED. THEREFORE THE IMPLANT AT TOOTH LOCATION #14 WAS REMOVED AND THE PATIENT WILL RETURN IN 3 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 17836546 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #14 WAS PLACED IN FEBRUARY AND THE PATIENT HAD SEVERAL RECURRENT INFECTIONS NEAR THE IMPLANT SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS WITH THE IMPLANT STILL IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 17836258 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON FOLLOW UP, THE ITEM NUMBER WAS UPDATED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16583166 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PAIN WHEN CHEWING. IMPLANT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 15893693 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT PATIENT RETURNS APPROXIMATELY ONE MONTH AFTER REMOVAL OF TOOTH #14(UNIVERSAL) AND PLACEMENT OF IMPLANT. PATIENT STATES THINGS SEEM TO BE HEALING MORE SLOWLY THAN WHAT HE HAS EXPERIENCED WITH PRIOR IMPLANTS. UPON EXAMINATION, IMPLANT IS STABLE, MILD SOFT TISSUE SETTING AGAINST THE BUCCAL SURFACE ON THE IMPLANT WITH A SMALL CREVICE HAVING FORMED BETWEEN THE BUCCAL GINGIVAL MARGIN IN THE HEALING CAP. NO VISIBLE DEBRIS. HEALING CAP REMOVED AND THE SITE IRRIGATED WITH PERIDEX. A COVER SCREW WAS PLACED AND GELFOAM TUCKED INTO THE GINGIVAL DEFECT. NO SIGNS OF INFECTION. PATIENT RETURNED APPROXIMATELY AFTER TWO WEEKS AND SOFT TISSUE DEFECT PERSIST, SUBTLE EXPOSURE OF SOME OF THE CRESTAL PORTION OF THE IMPLANT SHOULDER. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274966 ↗
• InjuryJul 11, 2022Adverse 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.

  Patient problems: Osteolysis

  MAUDE report 14976090 ↗
• InjuryJan 28, 2022Adverse 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 #19.

  Patient problems: Unspecified Infection

  MAUDE report 13385770 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PERI-IMPLANTITIS . IMPLANT RESTORED, CROWN BECAME LOOSE, REMOVED CROWN AND DISCOVERED IMPLANT AT TOOTH SITE # 30 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PATIENT RETURNING FOR 2 WEEK FOLLOW UP AND IN 3 MONTHS FOR IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PERI-IMPLANTITIS, INFECTION & BONE LOSS, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12577363 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE PERI-IMPLANTITIS AND THE AREA WAS GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12147405 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 12094292 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE TSVT6B13 IMPLANT. TOOTH SITE # 18. SITE WAS GRAFTED PRIOR TO PLACEMENT.

  Patient problems: No Information

  MAUDE report 10733549 ↗