Tapered Screw-Vent® TSVMWH13Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024344167), received between Jul 27, 2023 and Sep 30, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 Problem1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT IN CLINIC TO HAVE SEVERAL TOOTH EXTRACTIONS & NOTED IMPLANT #5 WAS LOOSE. IMPLANT REMOVED DUE TO PERIIMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20336854 ↗MalfunctionJul 27, 2023Component Missing; Component Missing
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17406314 ↗
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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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