Tapered Screw-Vent® TSVT4H11Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024344204), received between May 20, 2022 and May 22, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Fracture” (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 Problem6
- Fracture1
Patient problems
- Osteolysis4
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Adverse 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, TOOTH #14.
Patient problems: Unspecified Infection
MAUDE report 22073927 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21355111 ↗InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BONE LOSS REPORTED. TOOTH #'S 3 AND 5. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 18591916 ↗InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS FOUND IN PATIENT'S FILE. BONE LOSS.
Patient problems: Osteolysis
MAUDE report 18213069 ↗InjuryJul 28, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 FRACTURED AT THE INTERNAL HEX AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15121558 ↗InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED RECURRENT INFECTION OVER LAST FEW YEARS AND FAILED SURGERY REPAIR. TOOTH 4. IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15106070 ↗InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT RETURN WITH PAIN, IMPLANT REMOVED. TOOTH 12.
Patient problems: Pain
MAUDE report 14459443 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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