NA LPC441URecalls & reported problems
ZimVie US Corp LLC · LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868020950), received between Jul 14, 2021 and Sep 17, 2024 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
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.
MalfunctionSep 17, 2024Fracture; Fracture
IT WAS REPORTED THAT 2 ABUTMENTS FRACTURED AT THE SCREW OF THE ABUTMENTS AT TOOTH SITES 25-26, DISCOVERED AT ANNUAL REVISION. BOTH ABUTMENTS WERE REMOVED. PROCEEDING WAS COMPLETED WITH ANOTHER ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236631 ↗MalfunctionJul 14, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165404 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.