CERTAIN® ILPC442URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) · Class 2 · Implant
Quick summary
This is a ZimVie CERTAIN low profile one-piece dental abutment, the part that connects an implant to a crown. The 29 adverse event reports mostly describe the abutment breaking, sometimes leaving a broken screw piece stuck inside the implant; a few mention pain, inflammation, or the abutment shifting. There are no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00844868021063), received between Feb 12, 2021 and Feb 18, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (25 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
- Fracture25
- Unintended Movement3
- Adverse Event Without Identified Device or Use Problem1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Inflammation2
- Pain2
- Discomfort1
- Failure of Implant1
- No Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378727 ↗MalfunctionFeb 18, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378630 ↗MalfunctionDec 2, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692624 ↗InjuryOct 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SCREW PORTION OF A LOW PROFILE ABUTMENT FRACTURED IN THE IMPLANT AT TOOTH SITE #29 AND THEY WERE UNABLE TO REMOVE THE BROKEN PORTION FROM THE IMPLANT. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348706 ↗MalfunctionOct 20, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334671 ↗MalfunctionSep 3, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951271 ↗MalfunctionAug 27, 2025Unintended 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 22903386 ↗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 22477080 ↗MalfunctionJul 11, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO DENTAL ABUTMENTS FRACTURED BY THE SCREW. NO IMPACT ON THE PATIENT WAS REPORTED. PROCESS COMPLETED WITH OTHER ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476887 ↗MalfunctionJun 13, 2025Fracture; Fracture
THE DOCTOR REPORTED THAT THE ABUTMENT FRACTURED AT THE SCREW AREA. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200375 ↗MalfunctionJul 5, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT AT TOOTH SITE 36 LOOSENED AND WHILE TRYING TO REMOVE THE CAP, THE ABUTMENT WAS REMOVED. ABUTMENT WAS PLACED ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679570 ↗MalfunctionMay 21, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Discomfort
MAUDE report 19360582 ↗MalfunctionMar 28, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19000849 ↗MalfunctionMar 28, 2024Fracture; Fracture
IT WAS REPORTED LOCATORS AND SCREW FRACTURED. DOCTOR WAS ABLE TO RETRIEVE FRACTURED PIECES FROM IMPLANT. NO FURTHER IMPACT, PATIENT WILL RETURN FOR REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18999715 ↗MalfunctionMar 28, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18999494 ↗MalfunctionFeb 23, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED AN IMPLANT WAS PLACED, THEN A DIEM MUA WAS PLACED WITH A HEALING CAP TO SUTURE. WHEN FINISHING SUTURING, THE DOCTOR WENT TO TAKE OFF THE HEALING CAP TO PLACE AN IMPRESSION COPING AND THE ENTIRE ABUTMENT CAME UNSCREWED WITH THE HEAL CAP ATTACHED AT TOOTH SITE #19. THE IMPLANT DID NOT COME OUT, TO PLACE THE HEALING CAP THE DOCTOR USED THE THUMB DRIVER TO PLACE THE HEALING CAP. WHEN THE DOCTOR SEATED THE ABUTMENT, THE 3I PROSTHETIC KIT (NPSDKO)TO TORQUE THE ABUTMENT IN AT 10 NCM. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE BY PLACING A NEW 3I STRAIGHT MUA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773480 ↗MalfunctionDec 28, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408674 ↗MalfunctionDec 28, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408613 ↗MalfunctionDec 28, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408557 ↗MalfunctionJun 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17043460 ↗MalfunctionJun 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17043387 ↗MalfunctionJan 3, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE TRYING TO PLACE THE LOW-PROFILE ABUTMENT, THE SCREW FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16091101 ↗MalfunctionOct 19, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW WAS FOUND LOOSE AT THE SITE. UPON INVESTIGATION IT WAS ACTUALLY FRACTURED AND WAS REMOVED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 15634018 ↗MalfunctionJul 21, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENT FRACTURED AT THE SCREW OF THE ABUTMENT. TOOTH LOCATION 37. ABUTMENT AT 37 (ILPC442U) WAS SUCCESFULLY REMOVED AND IMPLANT REMAINS IN MOUTH. ABUTMENTS PLACED ON (B)(6) 2019.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073958 ↗MalfunctionMay 18, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE LOW PROFILE LOOSENS, IT LOSES ITS TIGHTNESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432841 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.