NA UNIHTRecalls & reported problems
ZimVie US Corp LLC · TITANIUM HEXED UNISCREW · Class 2 · Implant
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868017318), received between Jul 8, 2020 and Sep 23, 2026 — classified as 1 injury, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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
- Fracture18
- Mechanical Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fracture
The doctor reports that the dental screw failed because it fractured by the body.The doctor reports that the procedure was concluded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865038 ↗MalfunctionJun 13, 2025Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement
DOCTOR REPORTED THAT THE RECEIVED SCREW WAS NOT WORKING CORRECT AND LOOSENED. THE PROCESS WAS NOT COMPLETED WITH ANOTHER INSTRUMENT. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201617 ↗MalfunctionNov 15, 2024Fracture; Fracture
IT WAS REPORTED THAT SCREWS FRACTURED. TOOTH LOCATION 32 AND 34.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693898 ↗MalfunctionNov 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693841 ↗MalfunctionMay 1, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE PATIENT PRESENTED WITH A CROWN AND IMPLANT IN THE MOUTH (SIMILAR TO THE PREVIOUS OCCURRENCE IN 2023) AND THAT A SURGICAL INTERVENTION WAS NECESSARY TO UNCOVER THE (IOI) AND REMOVE SCREW THAT WAS FRACTURED IN THE HEAD, THE PROCEDURE WAS NOT COMPLETED. TYPE OF BONE AND AFFECTED DENTAL POSITION: UNKNOWN. THE SCREW FRACTURED AT THE HEAD, RIGHT AT THE CONNECTION WITH THE BODY OF THE SCREW, AND IT WAS SUCCESSFULLY REMOVED IN ITS ENTIRETY, BOTH HEAD AND BODY, (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19225591 ↗MalfunctionAug 29, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE, NEED TO REMOVE AND PLACE A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639820 ↗MalfunctionAug 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17437787 ↗MalfunctionMay 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17006284 ↗MalfunctionMay 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17006085 ↗MalfunctionMay 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17006072 ↗InjuryJan 20, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16218461 ↗MalfunctionJan 20, 2023Fracture; Fracture
THE DOCTOR REPORTS THAT THE SCREW FRACTURED AND THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER SCREW. THE AFFECTED DENTAL POSITION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217785 ↗MalfunctionApr 13, 2022Fracture; Fracture
DOCTOR REPORTED THAT SCREW FRACTURED AT THE THREAD OF THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14098941 ↗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 12882139 ↗MalfunctionOct 22, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681589 ↗MalfunctionOct 22, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681558 ↗MalfunctionApr 30, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11753713 ↗MalfunctionApr 30, 2021Fracture; Fracture
DOCTOR REPORTED THAT THE SCREW FAILED DUE TO A FRACTURE. THE SCREW AND FRACTURED PARTS WERE REMOVED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11753543 ↗MalfunctionJul 8, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10244431 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.