Tapered Screw-Vent® Implant System HC455Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024015074), received between Apr 7, 2020 and Jul 22, 2025 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (10 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
- Positioning Failure10
- Mechanical Problem2
- Incomplete or Inadequate Connection1
- Separation Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Information2
- Abscess1
- Pain1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565144 ↗MalfunctionApr 25, 2025Positioning Failure; Positioning Failure
DOCTOR REPORTED THAT SCREW DOES NOT WORK, IT DOES NOT SCREW PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908171 ↗InjuryMar 20, 2024Separation Problem; Separation Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18939164 ↗MalfunctionJan 2, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE DOCTOR FOLLOWED THE TSV SURGICAL PROCEDURES TO PLACE THE HEALING COLLAR. HOWEVER, THE DOCTOR COULD NOT SCREW THE HEALING COLLAR INTO THE IMPLANT. SO, IT WAS REPLACED IT WITH A NEW HEALING COLLAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18425657 ↗MalfunctionJul 6, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DOCTOR CONFIRMED HE FINISHED THE PROCEDURE WITH ANOTHER HEALING ABUTMENT. HC455 DID NOT FIT WITH THE IMPLANT¿S THREAD, IMPLANT ITSELF SEEMED OKAY AND WAS NOT REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17275178 ↗MalfunctionApr 12, 2023Positioning Failure; Positioning Failure
THE HEALING COLLAR CAN'T BE SCREWED. ANOTHER HEALING COLLAR HELD AT THE DENTAL OFFICE WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16727649 ↗MalfunctionMar 23, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT HAD DAMAGED THREADS. ANOTHER HEALING ABUTMENT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13862462 ↗MalfunctionMar 23, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE THREADS OF THE HEALING ABUTMENT WAS DEFECTIVE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HEALING ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13861799 ↗MalfunctionMar 1, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT WAS PLACED AND THE HEALING COLLAR WOULD NOT SCREW INTO IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13633038 ↗MalfunctionDec 13, 2021Positioning Failure; Positioning Failure
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12982829 ↗MalfunctionAug 9, 2021Positioning Failure; Positioning Failure
CUSTOMER REPORTED THAT THE HEALING ABUTMENT DID NOT SEAT IN THE IMPLANT. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER HEALING ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12295970 ↗MalfunctionMay 14, 2021Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824204 ↗MalfunctionApr 23, 2021Unintended Movement; Unintended Movement
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Abscess; Pain
MAUDE report 11716629 ↗MalfunctionJul 30, 2020Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10343980 ↗MalfunctionApr 7, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9933371 ↗
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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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