Tapered Screw-Vent® TSVT6B8Recalls & 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 dental implant has 107 reports, no deaths and 103 injuries. Many reports describe bone loss around the implant, infection around it, and pain, and some describe implants becoming loose and being removed. A report describes threads stripped inside the implant that needed a special tool to repair. 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
- 105
- Deaths reported
- 0
- Injuries reported
- 102
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00889024019911), received between Oct 4, 2019 and May 6, 2026 — classified as 102 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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 Problem100
- Fracture1
- Mechanical Problem1
- Patient-Device Incompatibility1
- Separation Failure1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection49
- Osteolysis41
- Inflammation18
- No Clinical Signs, Symptoms or Conditions17
- Pain17
- No Information15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Erosion4
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #3. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25092757 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. PT REPORTED PAIN IN SITE FOR 2 WEEKS. CALLED ME AT HOME ON WEEKEND & SAID IMPLANT WAS LOOSE. REPORTED IT CAME OUT A DAY AFTER. SAW PATIENT IN OFFICE (B)(6) 2026 TO CONFIRM. PT HAD LOST BONE L OF IMPLANT 6 WEEKS PRIOR. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24575362 ↗InjuryDec 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING, INFLAMMATION AND PAIN.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23733236 ↗InjuryNov 11, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT HAD SEVERE BONE LOSS AND HAD BECAME LOOSE. THE BONE WAS GRAFTED FOLLOWING THE GRAFT REMOVAL IN ANTICIPATION OF A REPLACEMENT IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION AND PAIN.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23525886 ↗InjuryNov 6, 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
MAUDE report 23486295 ↗InjurySep 15, 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 #2 WAS VERY LOOSE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23051363 ↗InjurySep 11, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 23025112 ↗InjurySep 9, 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 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 23003111 ↗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 #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 22999476 ↗InjuryAug 1, 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 #19 WAS REMOVED DUE TO SINUS PERFORATION. IT WAS REPORTED THAT THE IMPLANT HAD FAILED DUE TO SINUS COMMUNICATION. A SINUS ELEVATION PROCEDURE WAS CONDUCTED TO PROMOTE PATIENT HEALING.
Patient problems: Sinus Perforation
MAUDE report 22688624 ↗InjuryJul 24, 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 PERIIMPLANTITIS. IMPLANT BECAME INFECTED FAILING TO INTEGRATE. WILL ALLOW SITE TO HEAL TRADITIONALLY AND REATTEMPT IN 2-3 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22592914 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22120216 ↗InjuryMay 24, 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 22082173 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT BECAME INFECTED, FAILING TO INTEGRATE. THE IMPLANT WAS REMOVED. TOOTH LOCATION IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21941352 ↗InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC COMPLAINING OF A LOOSE IMPLANT CROWN. UPON INSPECTION, THE IMPLANT AT TOOTH LOCATION #3 SUFFERED BONE LOSS AND LOSS OF INTEGRATION WITH INFECTION. THE IMPLANT WAS REMOVED IMMEDIATELY TO ALLOW HEALING. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION, PAIN, EDEMA, INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21514742 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 21503702 ↗InjuryOct 21, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 20491957 ↗InjurySep 12, 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: Unspecified Infection
MAUDE report 20199392 ↗InjuryAug 13, 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: Bone Fracture(s)
MAUDE report 19977265 ↗InjuryJun 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection
MAUDE report 19611687 ↗InjuryJun 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT COMPLAINT OF IMPLANT BEING LOOSE, UPON EVALUATION PERI-IMPLANTITIS WAS EVIDENT. DURING EXAM IMPLANT WAS MOBILE, TORQUE TEST WAS PERFORMED IMPLANT REMOVED AND BONE GRAFT PLACED. SYMPTOMS AS A RESULT OF THE EVENT: MOBILE IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19595553 ↗InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #3 SHOWED ACUTE BONE LOSS AND CAME RIGHT OUT WITH THE HEALING COLLAR DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19579627 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #30 WAS REMOVED DUE TO AN INFECTION DISCOVERED IN POST OP PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. PAIN.
Patient problems: Unspecified Infection
MAUDE report 19459656 ↗InjuryMay 9, 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
MAUDE report 19280392 ↗InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19146521 ↗
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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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