Tapered Screw-Vent® TSV4B16Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent TSV4B16 is a root-form endosseous dental implant used as a tooth replacement anchor. The 38 adverse event reports mostly describe implants that failed to fuse with the jaw or became infected, with several needing surgical removal, along with pain and bone loss around the implant site. Reports also mention packaging that arrived unsealed and a few broken or separated parts. No deaths were reported, but 31 injuries and 7 malfunctions were. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00889024019256), received between Feb 4, 2020 and Jul 30, 2026 — classified as 32 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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
- Adverse Event Without Identified Device or Use Problem29
- Unsealed Device Packaging5
- Fracture2
- Separation Failure2
- Loss of Osseointegration1
- Mechanical Problem1
Patient problems
- Unspecified Infection22
- No Clinical Signs, Symptoms or Conditions14
- Osteolysis13
- Pain8
- Inflammation6
- No Code Available2
- No Information2
- Discomfort1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a bone loss. Tooth site 42.
Patient problems: Osteolysis
MAUDE report 50082725 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25301480 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #13 WERE REMOVED DUE TO PERI-IMPLANTITIS, AND NON-INTEGRATION. SYMPTOMS AS A RESULT OF THE EVENT WAS PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23416743 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23416425 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 22749462 ↗MalfunctionApr 30, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935389 ↗InjuryApr 25, 2025Fracture; Fracture
IT WAS REPORTED A MOUNT FRACTURE. THE GREEN IMPLANT CAP WAS BROKEN, MAKING IT IMPOSSIBLE TO INSERT THE STERILE IMPLANT. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908309 ↗InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20577565 ↗InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20577557 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED THE ANTIBIOTIC ON (B)(6) 2024 FOR 7 DAYS TO TREAT INFECTION AT IMPLANT SITE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20536425 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO INFECTION SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20522151 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH SITES #25 AND #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19395627 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. TOOTH SITES #25 AND #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19395528 ↗InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTED EPISODES OF SUPPURATION AROUND THE IMPLANT AT TOOTH LOCATION #8 WITH 8MM POCKET PROBING DEPTH ON THE DISTAL OF THE IMPLANT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Purulent Discharge; Unspecified Infection
MAUDE report 19143478 ↗MalfunctionApr 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
THE DISTRIBUTOR REPORTED THAT THE VIAL CAPS FOR THE IMPLANTS WERE BROKEN/CRACKED UPON RECEIPT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011354 ↗MalfunctionApr 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
THE DISTRIBUTOR REPORTED THAT THE VIAL CAPS FOR THE IMPLANTS WERE BROKEN/CRACKED UPON RECEIPT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011290 ↗MalfunctionApr 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
THE DISTRIBUTOR REPORTED THAT THE VIAL CAPS FOR THE IMPLANTS WERE BROKEN/CRACKED UPON RECEIPT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011263 ↗MalfunctionApr 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
THE DISTRIBUTOR REPORTED THAT THE VIAL CAPS FOR THE IMPLANTS WERE BROKEN/CRACKED UPON RECEIPT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011234 ↗MalfunctionApr 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
THE DISTRIBUTOR REPORTED THAT THE VIAL CAPS FOR THE IMPLANTS WERE BROKEN/CRACKED UPON RECEIPT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011197 ↗MalfunctionDec 4, 2023Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18264067 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 17785893 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 17781055 ↗InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17414126 ↗InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #13 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 17378988 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND BONE LOSS WITH PAIN AT IMPLANT TOOTH SITE #13. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17117452 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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