CERTAIN® ILPC342URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) · Class 2 · Implant
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868021100), received between Jan 31, 2020 and Apr 30, 2026 — classified as 1 injury, 15 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
- Unintended Movement2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Information2
- Inflammation1
- Pain1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CONICAL ABUTMENT WAS FRACTURED AT THE SCREW INSIDE IMPLANT ON TOOTH SITE #15. THE DOCTOR WAS ABLE TO REMOVE THE BROKEN FRAGMENT FROM THE IMPLANT. ABUTMENT PLACED ON (B)(6) 2023 AND REMOVED ON (B)(6) 2026. PATIENT SUFFERED FROM PAIN AND INFLAMMATION. PROCEDURE WAS COMPLETED. BONE DENSITY TYPE: III.
Patient problems: Inflammation; Pain
MAUDE report 25042524 ↗MalfunctionJan 26, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW IN THE IMPLANT AT TOOTH SITE #27 WAS DAMAGED. THE SCREW WILL BE REPAIRED ONCE A REPLACEMENT PART IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184360 ↗MalfunctionJan 5, 2026Unintended Movement
IT WAS REPORTED THAT ABUTMENT LOOSENED AT SITE # 9. PATIENT SAW GD FOR REGULAR EXAM AND THEY NOTICED HYBRID WAS LOOSE. PROCEDURE COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968017 ↗MalfunctionJan 5, 2026Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23967952 ↗MalfunctionJul 24, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585524 ↗MalfunctionJul 10, 2025Fracture; Fracture
IT WAS REPORTED AN ABUTMENT FRACTURED AT THE SCREW PART INSIDE THE IMPLANT. ABUTMENT WAS REMOVED COMPLETELY AND PROCEDURE WAS COMPLETED PLACING A NEW LOW PROFILE ABUTMENT. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467446 ↗MalfunctionMar 25, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL ABUTMENT LOCATED IN POSITION NUMBER #14 FAILED BECAUSE IT FRACTURED BY THE SCREW. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER ABUTMENT. BONE TYPE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18973217 ↗MalfunctionNov 8, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SCREW FROM THE MULTI UNIT PROSTHESIS FRACTURED. TOOTH LOCATION 38.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091143 ↗MalfunctionAug 2, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A CHECK UP THE DOCTOR NOTICED THAT THE ABUTMENT SCREW WAS FRACTURED. DOCTOR CLEANED UP THE AREA AND REPLACE THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17445394 ↗MalfunctionOct 6, 2022Fracture; Fracture
IT WAS REPORTED THAT PATIENT HAD CROWN MOBILITY. ABUTMENTS WERE OBSERVED TO BE FRACTURED AT THE SCREW OF THE ABUTMENT AND WERE REMOVED. PROCEDURE WERE COMPLETED WITH NEW LOW PROFILE ABUTMENTS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15549475 ↗MalfunctionOct 6, 2022Fracture; Fracture
IT WAS REPORTED THAT PATIENT HAD CROWN MOBILITY. ABUTMENTS WERE OBSERVED TO BE FRACTURED AT THE SCREW OF THE ABUTMENT AND WERE REMOVED. PROCEDURE WAS COMPLETED WITH NEW LOW PROFILE ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15549426 ↗MalfunctionJun 30, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENT FRACTURED ON THE SCREW PORTION ON 1 PIECE ABUTMENT. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14877169 ↗MalfunctionJun 30, 2022Fracture; Fracture
IT WAS REPORTED THAT ABUTMENT FRACTURED ON THE SCREW PORTION ON 1 PIECE ABUTMENT. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14877164 ↗MalfunctionJun 18, 2021Fracture; Fracture
IT WAS REPORTED THAT A SINGLE PIECE ABUTMENT FRACTURED AT TOOTH LOCATION 32. NO IMPACT TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12025973 ↗InjuryDec 28, 2020Fracture; Fracture
IT WAS REPORTED THAT WHILE PLACING THE ABUTMENT, IT FRACTURED AT THE SCREW PORTION. THE SCREW COULD NOT BE ENTIRELY REMOVED FROM THE IMPLANT, PROCEDURE WAS DELAYED BY 30 MINUTES.
Patient problems: No Information
MAUDE report 11076918 ↗MalfunctionJan 31, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9652015 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.