GOLD-TITE® UNIHGRecalls & reported problems
ZimVie US Corp LLC · GOLD-TITE® HEXED UNISCREW · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868017301), received between Sep 28, 2020 and Nov 18, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (4 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
- Unintended Movement4
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703859 ↗MalfunctionNov 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703821 ↗MalfunctionNov 18, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15825707 ↗MalfunctionNov 18, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN ABUTMENT SCREW LOOSENED IN PATIENT'S MOUTH. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15824608 ↗MalfunctionNov 18, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ABUTMENT SCREW LOOSENED. DOCTOR RETIGHTENED THE SCREW. NO FURTHER INFORMATION AVAILABLE. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15824512 ↗MalfunctionJul 21, 2022Fracture; Fracture
IT WAS REPORTED THAT THE SCREW FRACTURED AT THE BODY. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073407 ↗MalfunctionSep 28, 2020Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10592016 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- 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.