Tapered Screw-Vent® TSVTH13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024344310), received between Jan 28, 2021 and Jun 12, 2026 — classified as 16 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Mechanical Problem1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection11
- Pain10
- Inflammation5
- Osteolysis5
- No Code Available2
- Abscess1
- Swelling/ Edema1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OFFICE WITH THE IMPLANT AT TOOTH SITE #7 INFECTED. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25490825 ↗InjuryOct 28, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23400067 ↗InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT ONE OF THE TWO IMPLANTS PRESENTS DAMAGED THREADS AND THE OTHER IMPLANT HAD TO BE REMOVED DUE TO AN INFECTION. THE DOCTOR REPORTS PAIN. THE PROCEDURE WAS NOT COMPLETED. THE AFFECTED DENTAL POSITIONS ARE 13 AND 26. THIS COMPLAINT REFERS TO THE INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 23400056 ↗InjuryJul 11, 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 #11 WAS MOBILE WHEN WE TRIED TO UNCOVER IT. THE IMPLANT WAS REMOVED DUE TO INFECTION. THE AREA WAS CLEANED OUT WITH DOXYCYCLINE AND BONE PUTTY WAS PLACED.
Patient problems: Unspecified Infection
MAUDE report 22484362 ↗InjuryJul 10, 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 #28 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 22476079 ↗InjuryJul 25, 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 #27 WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19827584 ↗InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATION #23 AND #25 WERE EASILY REMOVED WITH AN IMPLANT DRIVER DURING THE IMPLANT UN-COVERY PROCESS DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19007204 ↗InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT CAME IN WITH PAIN/DISCOMFORT, PUSS DRAINAGE. REMOVED IMPLANT DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION. TOOTH # 12.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 18480317 ↗InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PT. HAD IMPLANTS PLACED IN #'S 5, 8, 10, & 12 SITES FOLLOWING EXTRACTIONS (SAME DAY) ON (B)(6) 2023. DUE TO INFECTION #12 REMOVED DUE TO INFECTION ON (B)(6) 2023. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18437167 ↗InjuryOct 11, 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 IMPLANT TOOTH SITE #23, WITH ASSOCIATED PAIN AND INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17917354 ↗InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #9 WAS REMOVED DUE TO CHRONIC PAIN.
Patient problems: Pain
MAUDE report 16187930 ↗InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #12 FAILED AND WAS REMOVED DUE TO PROGRESSING BONE LOSS. REGENERATED BONE FOR FUTURE IMPLANT.
Patient problems: Osteolysis
MAUDE report 14800189 ↗InjuryApr 4, 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 # 5 WAS REMOVED DUE TO ACUTE INFECTION 3 DAYS POST GO. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 14000394 ↗InjuryMay 25, 2021Adverse 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: Inflammation; Pain; Swelling/ Edema
MAUDE report 11876140 ↗InjuryFeb 4, 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 # 6 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; No Code Available
MAUDE report 11279698 ↗InjuryJan 28, 2021Adverse 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 AND BONE LOSS AT THE SITE WITH SEVERE PAIN AND INFLAMMATION. PATIENT WILL RETURN FOR A NEW IMPLANT. TOOTH #11.
Patient problems: Inflammation; No Code Available; Pain; Unspecified Infection
MAUDE report 11247737 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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