GOLD-TITE® UNISGRecalls & reported problems
ZimVie US Corp LLC · GOLD-TITE® SQUARE UNISCREW · Class 2 · Implant
All models of GOLD-TITE (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00844868017325), received between Sep 13, 2021 and Feb 11, 2026 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (13 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
- Fracture13
- Unintended Movement8
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Unintended Movement
IT WAS REPORTED THAT THE SCREWS KEEP COMING LOOSE IN THE PATIENTS¿ MOUTH. THE SCREWS WERE RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316223 ↗MalfunctionFeb 11, 2026Unintended Movement
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316114 ↗InjuryDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT LOST THE IMPLANT AT TOOTH SITE 34 DUE TO NON-INTEGRATION. ON 2021 GOLDTITE SCREW AT TOOTH SITE 35 FRACTURED AND THE SCREW WAS REMOVED. ON (B)(6) 2025 GOLDTITE SCREW AT TOOTH SITE 36 FRACTURED, BUT THIS TIME IT WAS IMPOSSIBLE TO REMOVE THE SCREW. DOCTOR DECIDED TO PUT TO SLEEP IMPLANT AT TOOTH SITE 36, AND A NEW IMPLANT WILL BE PLACED AT TOOTH SITE 34. IMPLANT AT TOOTH SITE 36 WAS PLACED ON (B)(6) 2009. THIS REPORT REFERS TO SCREW FRACTURE AT TOOTH SITE 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776296 ↗MalfunctionNov 17, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570640 ↗MalfunctionMar 27, 2025Fracture; Unintended Movement; Fracture; Unintended Movement
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOOSE SCREW, THE SCREW FRACTURED WHEN THE CLINICIAN WAS RE-TORQUEING IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712109 ↗MalfunctionMar 17, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT SCREW LOOSENING AND WAS RETIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617916 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267452 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267418 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267321 ↗MalfunctionJan 29, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267286 ↗MalfunctionJan 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496419 ↗MalfunctionJan 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496411 ↗MalfunctionSep 26, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817003 ↗MalfunctionMay 9, 2023Unintended Movement; Unintended Movement
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894106 ↗MalfunctionApr 12, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED IN THE PATIENTS MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16725241 ↗MalfunctionMay 27, 2022Fracture; Fracture
IT WAS REPORTED A FRACTURE ON THE GOLD TILE SCREW. DOCTOR HAD EXPERIENCE THE SAME ISSUE BACK IN 2017 WITH THIS PATIENT. PATIENT IS BUXIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520403 ↗MalfunctionDec 30, 2021Unintended 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 13117237 ↗InjuryNov 29, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882102 ↗MalfunctionNov 29, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882085 ↗MalfunctionSep 13, 2021Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12460475 ↗
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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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