Tapered Screw-Vent® TSVM6H10Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024344044), received between Aug 31, 2021 and Dec 26, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Osteolysis2
- Unspecified Infection2
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT'S COLLAR AT TOOTH LOCATION # 14 FRACTURED AND THE CROWN WOULD STAY TORQUED. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020770 ↗InjuryJul 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17328358 ↗InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP AND THE IMPLANT AT TOOTH LOCATION #31 HAD FAILED REQUIRING REMOVAL DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15254599 ↗InjuryMay 12, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 14368754 ↗InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 15 LACKED PRIMARY STABILITY AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12394422 ↗
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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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