CERTAIN® GOLD-TITE® ILRGHGRecalls & reported problems
ZimVie US Corp LLC · CERTAIN® GOLD-TITE® LARGE HEXED SCREW · Class 2 · Implant
All models of CERTAIN GOLD-TITE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868006121), received between Aug 5, 2020 and Jun 9, 2025 — classified as 16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture14
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Information4
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
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 22165929 ↗MalfunctionMay 2, 2025Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21949443 ↗MalfunctionOct 18, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITES 45, 47, 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17955793 ↗MalfunctionOct 29, 2022Fracture; Fracture
IT WAS REPORTED THAT SCREW BROKE IN TOOTH SITE (PART OF A BRIDGE). TOOTH LOCATION: 14. BROKEN SCREW IS STILL IN THE PATIENT'S MOUTH AND WILL BE REMOVED IN THE NEXT FEW DAYS. IMPLANT REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695703 ↗MalfunctionOct 28, 2022Fracture; Fracture
IT WAS REPORTED THAT SCREW BROKE IN TOOTH SITE (PART OF A BRIDGE). TOOTH LOCATION: 12. BROKEN SCREW IS STILL IN THE PATIENT'S MOUTH AND WILL BE REMOVED IN THE NEXT FEW DAYS. IMPLANT REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15693777 ↗MalfunctionOct 5, 2022Fracture; Fracture
IT WAS REPORTED THAT SCREWS FRACTURED AND WERE REMOVED. PATIENT HAD TO RETURN TO PLACE NEW SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15543217 ↗MalfunctionOct 5, 2022Fracture; Fracture
IT WAS REPORTED THAT SCREWS FRACTURED AND WERE REMOVED PATIENT HAD TO RETURN TO PLACE NEW SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15543173 ↗MalfunctionAug 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED AT THE SITE. THE ABUTMENT SCREW WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 15162812 ↗MalfunctionAug 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED AT THE SITE. ABUTMENT SCREW WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 15162627 ↗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 12313241 ↗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 12313172 ↗MalfunctionMar 29, 2021Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11582473 ↗MalfunctionOct 15, 2020Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10683412 ↗MalfunctionOct 15, 2020Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10683363 ↗MalfunctionAug 12, 2020Fracture; Fracture
MalfunctionAug 5, 2020Fracture; Fracture
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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