CERTAIN® ILPC444URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) · Class 2 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00844868021049), received between Nov 6, 2020 and Jul 14, 2025 — classified as 5 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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
- Fracture14
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Failure of Implant1
- Inflammation1
- Insufficient Information1
- No Information1
- Osteolysis1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Fracture; Fracture
IT WAS REPORTED ONE MULTI-UNIT ABUTMENT FRACTURED BY THE SCREW PART. AND ONE RETAINING SCREW FRACTURED INSIDE THE OTHER ABUTMENT. ABUTMENTS WERE REMOVED. PROCEDURE WAS COMPLETED. THIS REPORT REFERS TO ABUTMENT FRACTURED BY THE SCREW PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22492506 ↗MalfunctionJul 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477019 ↗MalfunctionJun 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201065 ↗MalfunctionDec 23, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20999137 ↗InjuryOct 3, 2024Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE AND IMPLANT WAS REMOVED. TOOTH LOCATION 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20357375 ↗MalfunctionJul 31, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423917 ↗MalfunctionJun 15, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17133446 ↗InjuryFeb 17, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED WHEN TRYING TO PLACE IT. IT WAS IMPOSSIBLE TO REMOVE THE LOWER PART OF THE ABUTMENT FROM WITHIN THE IMPLANT AND THE IMPLANT HAD TO BE REMOVED. TOOTH LOCATION 15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16397301 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: BONE LOSS, PAIN, INFLAMMATION AND EDEMA.
Patient problems: Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 15698193 ↗InjuryAug 9, 2022Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189925 ↗MalfunctionAug 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED AT THE SITE. ABUTMENT WAS REMOVED WITHOUT CAUSING MAJOR DAMAGE. PROCEDURE WAS COMPLETED PLACING OTHER ABUTMENT.
Patient problems: Insufficient Information
MAUDE report 15163491 ↗InjuryJul 22, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED RESULTING IN IMPLANT REMOVAL.
Patient problems: Failure of Implant
MAUDE report 15083975 ↗MalfunctionAug 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12311739 ↗MalfunctionAug 12, 2021Fracture; Fracture
IT WAS REPORTED THAT THE SCREW OF THE ABUTMENT FRACTURED INSIDE THE IMPLANT, THE FRACTURED PARTS WERE REMOVED WITH NO DAMAGED TO THE IMPLANT. THE DOCTOR CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH AND THAT THE PROCEDURE WAS CONCLUDED WITH OTHER TOOLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12311730 ↗MalfunctionNov 6, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10801642 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.