Tapered Screw-Vent® Implant System TAC2Recalls & 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024018419), received between Apr 13, 2022 and Sep 18, 2026 — classified as 4 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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
- Fracture11
- Unintended Movement4
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fracture
Doctor reported screw fracture. Patient came referring mobility on bridge supported by implant, doctor noticed that multi-unit screw of one of the abutments of the 3 piece-bridge fractured. Procedure was completed with a new multi-unit of height 35.2 mm. Tooth site 14.Abutment placement date: (b)(6) 2018,Abutment removal date: (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816767 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT ABUTMENTS SCREW WAS FRACTURED. TOOTH LOCATION # 45 AND 47.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843133 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT ABUTMENTS SCREW WAS FRACTURED. TOOTH LOCATION # 45 AND 47.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843035 ↗MalfunctionMar 26, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED AT THE SCREW PORTION IN THE IMPLANT BUT WAS RETRIEVED. THE PATIENT HAS BEEN SCHEDULED TO REPLACE THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699292 ↗MalfunctionMar 12, 2026Fracture
DOCTOR REPORTED THAT PROSTHESIS AT TOOTH SITE 42 WAS LOOSE, ON THE X-RAY IT WAS NOTICED THAT ABUTMENT SCREW WAS FRACTURED. A NEW TAC2 WAS PLACED. PLACEMENT DATE: (B)(6) 2024, REMOVED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577683 ↗InjuryAug 26, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898598 ↗MalfunctionAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SCREW OF THE IMPLANT AT TOOTH SITE #45 (FDI) WAS BROKEN. THE IMPLANT WAS CONFIRMED TO HAVE BEEN INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22884858 ↗InjuryAug 19, 2025Fracture; Fracture
THE DOCTOR REPORTS A FRACTURE OF THE SCREW OF THE MULTI-UNIT ABUTMENT INSIDE THE IMPLANT, WHICH COULD NOT BE REMOVED USING THE RESCUE KIT. IMPLANT WAS REMOVED. TOOTH POSITION 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837232 ↗MalfunctionNov 20, 2024Unintended 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 20733790 ↗MalfunctionNov 20, 2024Unintended Movement; Unintended Movement
DOCTOR REPORTED THAT BRIDGE WAS IN MOUTH FOR ALMOST A YEAR AND WAS LOOSE THREE TIMES. DOCTOR NOTICED THAT IN THIS ABUTMENT THE SCREW AT TOOTH SITE 17 DID NOT SCREW PROPERLY ON TORQUE. ANOTHER TAC2 WAS PLACED. PLACEMENT DATE: (B)(6) 2023. THIS EVENT REFERS TO THE SECOND LOOSENING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733534 ↗MalfunctionNov 20, 2024Unintended 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 20733308 ↗MalfunctionNov 20, 2024Unintended Movement; Unintended Movement
DOCTOR REPORTED THAT AFTER PLACEMENT OF BRIDGE ON TACS, PATIENT REFERRED MOVEMENT OF THE BRIDGE 3 MONTHS AFTER DURING CHECK UP. THE BRIDGE ON THE MODEL SCREWS PROPERLY. BRIDGE WAS SENT TO LABORATORY AND THEY CONFIRMED THAT IT IS OK, THE PROBLEM SEEMED TO BE THE LOOSENING OF THE ABUTMENT. DOCTOR REMOVED THE TAC2 AT TOOTH SITE 26, PLACED ANOTHER ONE AND THE BRIDGE DOES NOT MOVE ANYMORE. PLACEMENT DATE: (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733045 ↗InjuryAug 22, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20029812 ↗InjuryJul 13, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17321439 ↗MalfunctionApr 13, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREWS FRACTURED AT TOOTH LOCATION 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14101314 ↗
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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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