Tapered Screw-Vent® Implant System 30AT346Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024013582), received between Nov 14, 2023 and Nov 14, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Unintended Movement; Unintended Movement
ABUTMENT LOOSENING WAS REPORTED. SEVERAL IMPLANTS WERE IMPLANTED ON (B)(6) 2022. THE IMMEDIATE LOADING WAS PERFORMED IN THE AFTERNOON. THE RESTORATION WAS DELIVERED. THERE WAS NO ADVERSE REACTIONS AFTER SURGERY. THE PATIENT CAME FOR RE-EXAMINATION ON (B)(6) 2023, AND THE ABUTMENT LOOSENING WAS FOUND, LEADING TO THE DEFORMATION OF SCREW. THE FORCE COULD NOT BE APPLIED TO LOCK TIGHTLY, CAUSING THE FAILURE. THE IMPLANT WAS THEN REMOVED. TOOTH SITE # 24-35.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129662 ↗InjuryNov 14, 2023Unintended Movement; Unintended Movement
ABUTMENT LOOSENING WAS REPORTED. SEVERAL IMPLANTS WERE IMPLANTED ON (B)(6), 2022. THE IMMEDIATE LOADING WAS PERFORMED IN THE AFTERNOON. THE RESTORATION WAS DELIVERED. THERE WAS NO ADVERSE REACTIONS AFTER SURGERY. THE PATIENT CAME FOR RE-EXAMINATION ON (B)(6), 2023, AND THE ABUTMENT LOOSENING WAS FOUND, LEADING TO THE DEFORMATION OF SCREW. THE FORCE COULD NOT BE APPLIED TO LOCK TIGHTLY, CAUSING THE FAILURE. THE IMPLANT WAS THEN REMOVED. TOOTH SITE # 24-35.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129582 ↗
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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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