CERTAIN® ILRGHTRecalls & reported problems
ZimVie US Corp LLC · CERTAIN® TITANIUM LARGE HEXED SCREW · Class 2 · Implant
Quick summary
This ZimVie CERTAIN titanium screw is a dental implant part. The 93 reports mostly describe screw fractures, with one loose screw; they usually mention no symptoms or patient impact. There were no deaths and no injuries. No recalls name this device. Reports fell from 10 to 5 over the last 12 months.
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
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00844868006138), received between Jan 30, 2020 and Aug 18, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Fracture” (92 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
- Fracture92
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions70
- No Information22
- Failure of Implant2
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300035 ↗MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299922 ↗MalfunctionMar 12, 2026Unintended Movement
IT WAS REPORTED THAT THE SCREWS WERE LOOSENED AND DID NOT HOLD THE CROWNS PROPERLY, AND THE SCREWS WERE REMOVED. NO OTHER SCREWS WERE USED IN EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581470 ↗MalfunctionFeb 3, 2026Fracture
THE DOCTOR REPORTED THAT THE 2 SCREWS FRACTURED BY THE BODY. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244273 ↗MalfunctionFeb 3, 2026Fracture
THE DOCTOR REPORTED THAT THE 2 SCREWS FRACTURED BY THE BODY. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244252 ↗MalfunctionOct 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401364 ↗MalfunctionOct 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400423 ↗MalfunctionOct 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400417 ↗MalfunctionJul 14, 2025Fracture; Fracture
IT WAS REPORTED A SCREW FRACTURE. THE PROCESS WAS COMPLETED WITH ANOTHER INSTRUMENT. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493078 ↗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 22200881 ↗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 22200870 ↗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 22200859 ↗MalfunctionJun 9, 2025Fracture; Fracture
IT WAS REPORTED THE FRACTURES OF TWO SCREWS AT TOOTH SITE 36/37. CROWN MOBILITY DUE TO SCREW FRACTURE. IMPLANTS ARE STILL PLACED ON THE PATIENT. SCREWS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2025. THE PROCESS WAS NOT COMPLETED. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22165964 ↗MalfunctionApr 23, 2025Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890216 ↗MalfunctionFeb 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 21353419 ↗MalfunctionJul 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SCREWS AT TOOTH SITES 41, 43 FRACTURED AT THE THREADS OF THE SCREW AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19738386 ↗MalfunctionJul 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SCREWS AT TOOTH SITES 41, 43 FRACTURED AT THE THREADS OF THE SCREW AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19738374 ↗MalfunctionJan 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18501688 ↗MalfunctionNov 6, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072058 ↗MalfunctionOct 18, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITES 45, 47, 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17955737 ↗MalfunctionOct 18, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITES 45, 47, 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17955699 ↗MalfunctionJul 27, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17408628 ↗MalfunctionJul 27, 2023Fracture; Fracture
IT WAS REPORTED THAT 3 SCREWS AT TOOTH SITES 13, 14 AND 16 FRACTURED AND HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17408462 ↗MalfunctionJul 27, 2023Fracture; Fracture
IT WAS REPORTED THAT 3 SCREWS AT TOOTH SITES 13, 14 AND 16 FRACTURED AND HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17408423 ↗MalfunctionMay 22, 2023Fracture; Fracture
IT WAS REPORTED THAT 2 SCREWS AT TOOTH SITES 41 AND 44 FRACTURED AT THE THREADS OF THE SCREWS AND WERE REMOVED. PROCEDURE WAS COMPLETED WITH OTHER SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973960 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.