Tapered Screw-Vent® TSVMWH8Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024344181), received between Sep 2, 2020 and May 31, 2025 — classified as 4 injuries, 2 malfunctions.
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 Problem4
- Mechanical Problem1
- Separation Failure1
Patient problems
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Osteolysis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22120503 ↗MalfunctionNov 17, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE INTERNAL THREADS ON IMPLANT ARE DAMAGED. TOOTH #14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159066 ↗InjuryMay 9, 2023Adverse 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 MEDICAL INFECTION. TOOTH SITE # 19 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 16894878 ↗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 LOCATIONS #14 AND #15 WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14978487 ↗InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH SITE #4.
Patient problems: Unspecified Infection
MAUDE report 14976855 ↗MalfunctionSep 2, 2020Separation Failure; Separation Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Information
MAUDE report 10485144 ↗
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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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