Tapered Screw-Vent® TSVM4H13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024344013), received between Nov 16, 2023 and May 9, 2025 — classified as 2 injuries, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Component Missing1
Patient problems
- Osteolysis2
- Unspecified Infection2
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC EXPERIENCING IMPLANT MOBILITY AT THE IMPLANT AT TOOTH LOCATION #10 AND THE DENTURE NOT FITTING PROPERLY. THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21995020 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 7 WAS REMOVED DUE TO BONE LOSS & INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19966856 ↗MalfunctionNov 16, 2023Component Missing; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18149648 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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