CERTAIN® ILPC341URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H) · Class 2 · Implant
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868021117), received between Feb 7, 2020 and May 8, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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
- Fracture10
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Information2
- Discomfort1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THAT THE MULTI UNIT ABUTMENT SCREWS FRACTURED. THE CLINICIAN WAS TRYING TO SCREW THE SCANBODY FOR TAKING IMPRESSIONS AND THE ABUTMENTS CAME TOGETHER. THE FRACTURED PART OF THE SCREW WAS REMOVED. TOOTH LOCATION 23 AND 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123397 ↗MalfunctionApr 7, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21783664 ↗MalfunctionNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706628 ↗MalfunctionMay 21, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Discomfort
MAUDE report 19360476 ↗MalfunctionNov 23, 2023Unintended 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 18197255 ↗MalfunctionMay 12, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16920350 ↗MalfunctionApr 12, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726544 ↗MalfunctionJan 26, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16245409 ↗InjuryOct 4, 2022Fracture; Fracture
IT WAS REPORTED THAT LOW PROFILE ABUTMENT FRACTURED AT THE SCREW OF THE ABUTMENT WHILE TAKING MEASURES. A PORTION REMAINED INSIDE THE IMPLANT AND IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15535619 ↗MalfunctionFeb 7, 2020Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED IN DENTAL SITE 14. THE IMPLANT IS IN GOOD CONDITION.
Patient problems: No Information
MAUDE report 9681271 ↗MalfunctionFeb 7, 2020Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED. THE IMPLANT IN DENTAL SITE 12 IS IN GOOD CONDITION.
Patient problems: No Information
MAUDE report 9681006 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.