Tapered Screw-Vent® TSV4H8Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024019348), received between Jun 29, 2022 and Apr 1, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24756620 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE #26 . IMPLANT WAS REMOVED. NO OTHER IMPACT ON THE PATIENT REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24615055 ↗
• InjuryDec 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 #27 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23794368 ↗
• InjurySep 19, 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 #19 & #30 WERE REMOVED DUE TO INFECTION. CLINICAL EXAM WAS CONSISTENT WITH IMPLANT MOBILITY AND ERYTHEMA. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23094942 ↗
• InjurySep 3, 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 36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22951170 ↗
• InjuryAug 8, 2025Adverse 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22754722 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #17 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED PAIN, EDEMA, AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22673777 ↗
• InjuryMay 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 #27 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22052503 ↗
• InjuryMar 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 #20 WAS REMOVED DUE TO BONE LOSS. FAILED IMPLANT WITH ADVANCED BONE LOSS STARTING IN 2020. IMPLANT WAS REMOVED AND SITE WAS DEBRIDED WITH CURETTAGE. BONE GRAFT WAS PLACED IN SITE #20. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO, BONE GRAFT NEEDS TO HEAL 3 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 21691379 ↗
• InjuryMar 11, 2025Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 21570878 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #29 HAD BONE LOSS AROUND THE IMPLANT AND WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 20028634 ↗
• InjuryMay 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BEEN DEALING W/LINCHEN PLANUS - HAS BEEN IN AND OUT OF OUR OFFICE SINCE 2022 IN DEALING W/PERI-IMPLANTITIS. SHE COMPLAINED TO HER DENTIST OF IMPLANT #5 BEING SORE. WENT IN AND HER DENTIST PULLED IMPLANT OUT. CAME IN TO US TO RE-EVALUTE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19430934 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WOULD NOT TAKE ANTIBIOTICS AFTER PLACEMENT OF IMPLANT AND DID NOT COME IN FOR FOLLOW UP CARE. ONLY WENT TO DENTIST IF HAVING PROBLEMS. FINALLY, THE PATIENT CAME BACK COMPLAINING OF PAIN AND IT WAS DISCOVERED THROUGH X-RAY (PA) THAT THERE WAS BONE LOSS AND PERI-IMPLANTITIS. CAME IN FOR A DEBRIDEMENT AND NEEDED TO REMOVE THE IMPLANT. CLEANED OUT AND RE-GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19361614 ↗
• InjuryApr 10, 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 45 46 & 47 FAILED DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. BONE TYPE: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19078737 ↗
• InjuryApr 10, 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 45 46 & 47 FAILED DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED. BONE TYPE: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19078640 ↗
• InjurySep 27, 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; Pain; Unspecified Infection

  MAUDE report 17825926 ↗
• InjuryAug 29, 2023Adverse 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 34 Y 35 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17641034 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Abscess; Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 17135290 ↗
• InjuryJun 1, 2023Adverse 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 17040427 ↗
• MalfunctionMar 29, 2023Component Missing; Component Missing

  THE DOCTOR REPORTS THAT AT THE TIME OF THE INTERVENTION, HE REALIZED THAT THE IMPLANTS WERE NOT INSIDE THE IMPLANT CONTAINER. THE AFFECTED DENTAL POSITIONS ARE UNKNOWN. THE DOCTOR CONFIRMS IN THE PER THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER 2 IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640969 ↗
• InjuryFeb 3, 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 16294795 ↗
• InjuryJan 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE DENTIST WAS REPLACING A CROWN, THE IMPLANT AT TOOTH LOCATION #30 WAS WOBBLING. AN INTERNAL EVALUATION SHOWED A FRACTURE OF THE IMPLANT, AND THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125135 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT PLACED AT TOOTH LOCATION #30 AND WAS GIVEN AN ANTIBIOTIC DOSE. DESPITE PREVENTIVE ANTIBIOTICS, THE PATIENT DEVELOPED A POST -OP INFECTION THAT PREVENTED THE IMPLANT FROM HEALING. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

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

  MAUDE report 15914585 ↗
• InjuryJun 29, 2022Fracture; Fracture

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE IN THE NECK AREA. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852865 ↗