Tapered Screw-Vent® Implant System 15AT312Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024012035), received between Jul 8, 2021 and Feb 13, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Unintended Movement2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Fracture
IT WAS REPORTED THAT THE PATIENT BROUGHT BACK THE FRACTURED RESTORATION (ABUTMENT FROM TOOTH SITE #44) WITH THE CROWN IN HIS HAND. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330917 ↗MalfunctionAug 20, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TAPERED ABUTMENT AT TOOTH SITE R24 (FDI) HAD FRACTURED. THE IMPLANT WAS COMPLETELY INTACT AND UNDAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854607 ↗InjuryNov 23, 2022Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15852532 ↗InjuryMay 18, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENTS FRACTURED AND IMPLANTS PLACED WERE REMOVED. PATIENT WOULD HAVE TO RETURN TO PLACE NEW IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14433051 ↗InjuryMay 18, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENTS FRACTURED AND IMPLANTS WERE REMOVED. PATIENT WOULD HAVE TO RETURN TO PLACE NEW IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432929 ↗MalfunctionJul 8, 2021Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12133542 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.