Tapered Screw-Vent® TSV6B8Recalls & 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 TSV6B8 is a root-form dental implant used to replace missing teeth. Most of the 72 reports describe implants that had to be taken out because of peri-implantitis, infection around the implant, or bone loss, often with pain, inflammation or an abscess; a few mention a cracked or bent part and an empty package. There are 69 injuries and no deaths. 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
- 72
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00889024019416), received between Nov 7, 2019 and Sep 29, 2026 — classified as 69 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 Problem65
- Fracture3
- Component Missing1
- Mechanical Problem1
- Patient-Device Incompatibility1
- Separation Failure1
Patient problems
- Unspecified Infection40
- Osteolysis28
- Pain21
- No Clinical Signs, Symptoms or Conditions14
- Inflammation13
- No Information8
- Abscess6
- No Code Available4
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to Peri-implantitis, tooth site 16.Patient suffered from inflammation and pain.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50931625 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #15 AND #23 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25444473 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25332087 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25331832 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN WITH DISCOMFORT AROUND THE IMPLANT AT TOOTH SITE #18. THE DOCTOR CHECKED AND FOUND PERI-IMPLANTITIS WITH ABSCESS. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24669137 ↗MalfunctionFeb 18, 2026Component Missing
IT WAS REPORTED THAT THE DOCTOR PREPPED THE TOOTH SITE AND WHEN THEY WENT TO OPEN THE IMPLANT, THERE WAS NO IMPLANT IN THE VIAL. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24375574 ↗InjuryDec 31, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT THE DOCTOR PLACED THE IMPLANT AT TOOTH SITE #3. WHEN THE DOCTOR TRIED TO REMOVE THE IMPRESSION COPING THE COPING WOULD NOT DISCONNECT FROM THE IMPLANT AND SEEMED BENT. THE IMPLANT WAS REMOVED AND THE BONE WAS GRAFTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936290 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23327313 ↗InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 FAILED TO INTEGRATE TO BONE. THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Unspecified Infection
MAUDE report 22998591 ↗InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22984025 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND IMPLANT PLACED IN 2022. NOTED MOBILITY, CROWN/ABUTMENT APPEAR SEATED. WIDENED P.D.L ON PA. PATIENT REPORTS THAT TOOTH/IMPLANT FELL OUT SPONTANEOUSLY. TOOTH #3. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22636274 ↗InjuryJul 12, 2025Adverse 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 PERI-IMPLANTITIS, AT TOOTH SITE #26.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22488334 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI IMPLANTITIS WITH BONE LOSS AT IMPLANT #27 AND WAS REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21603558 ↗InjuryMar 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 21504854 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21345861 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 BECAME LOOSE AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 21138955 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT THE IMPLANTS AT TOOTH SITES #3 & #14 WERE REMOVED DUE TO ALLERGIC REACTION. PATIENT DEVELOPED CONSTANT PAIN SINCE PLACEMENT OF IMPLANTS IN AREA 3 AND 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 20465529 ↗MalfunctionOct 3, 2024Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359654 ↗InjurySep 10, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20181015 ↗InjuryJul 8, 2024Adverse 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; Osteolysis; Unspecified Infection
MAUDE report 19698238 ↗InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S BODY REJECTED THE IMPLANT AT TOOTH SITE # 19 AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 19475893 ↗InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENT WITH PAIN, AFTER EXAMINATION WE OBSERVE INFECTION IN THE AREA, IMPLANT REMOVED, AREA CLEANED AND BONE GRAFTED. TOOTH SITE # 35.
Patient problems: Pain; Unspecified Infection
MAUDE report 19384832 ↗InjuryMay 13, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299421 ↗InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT THE IMPLANT AT TOOTH #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. I.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19087474 ↗InjuryAug 28, 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 #2 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 17632324 ↗
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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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