CERTAIN® ILPC443URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868021056), received between Dec 18, 2020 and Apr 14, 2026 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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
- Fracture12
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Information2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Fracture
DOCTOR REPORTED FRACTURE OF MULTIUNIT SCREWS TIGHTENED AT 10 N. PLACEMENT DATE: (B)(6) 2025, REMOVAL DATE: (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869883 ↗MalfunctionApr 14, 2026Fracture
DOCTOR REPORTED FRACTURE OF MULTIUNIT SCREWS TIGHTENED AT 10 N. PLACEMENT DATE:(B)(6) 2025. REMOVAL DATE: (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869863 ↗MalfunctionMar 30, 2026Fracture
DOCTOR REPORTS 3 ABUTMENTS THAT HAD TO BE REPLACED DUE TO DIFFERENT ISSUES: 1 ABUTMENT SCREW FRACTURED INSIDE THE IMPLANT; BROKEN FRAGMENT WAS REMOVED FROM THE IMPLANT. 1 ABUTMENT COULD NOT BE ADJUSTED PROPERLY AND THERE WA SNO PROBLEM WITH THE IMPLANT. 1 ABUTMENT COULD NOT BE SCREWED ALL THE WAY DOWN AND THAT THERE WAS NO PROBLEM WITH THE IMPLANT ITSELF. THIS REPORT REFERS TO FRACTURED SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728489 ↗MalfunctionSep 2, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22945104 ↗MalfunctionAug 18, 2025Fracture; Fracture
IT WAS REPORTED THE RETAINING SCREW AND THE ABUTMENT, BOTH FRACTURED AT THE SCREW PART. PROCEEDING WAS COMPLETED WITH DIFFERENT PRODUCTS. THIS REPORT REFERS TO ABUTMENT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826932 ↗MalfunctionFeb 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED INSIDE THE IMPLANT #42 AND THE ABUTMENT WAS REMOVED. PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342660 ↗MalfunctionFeb 10, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350590 ↗InjuryJul 21, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENT FRACTURED AT THE SCREW OF THE ABUTMENT. TOOTH LOCATION 37. ABUTMENT AT 37 (ILPC442U) WAS SUCCESSFULLY REMOVED AND IMPLANT REMAINS IN MOUTH. ABUTMENT PLACED ON (B)(6) 2019.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073856 ↗MalfunctionDec 7, 2021Fracture; Fracture
IT WAS REPORTED THE SCREW OF THE ABUTMENT FRACTURED, THE FRACTURE PORTION WAS REMOVED FROM THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12947275 ↗MalfunctionJul 2, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12112032 ↗MalfunctionFeb 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11320327 ↗MalfunctionDec 18, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11036166 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.