Tapered Screw-Vent® TSVM4B13Recalls & 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 is a screw-shaped root implant used to replace a tooth. The 52 reports describe implants that had to be taken out, mostly because of infection around the implant site (peri-implantitis), along with pain, inflammation, swelling, and bone loss around the implant. There are 52 injuries and no deaths, and 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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00889024019645), received between Apr 27, 2020 and Jan 12, 2026 — classified as 52 injuries.
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 Problem52
Patient problems
- Unspecified Infection41
- Pain18
- Osteolysis17
- Inflammation15
- Swelling/ Edema5
- No Clinical Signs, Symptoms or Conditions4
- Purulent Discharge3
- Abscess2
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24046916 ↗InjuryOct 31, 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 #12 WAS REMOVED DUE TO INFECTION AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23442106 ↗InjuryAug 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. TOOTH SITE #14. SYMPTOM REPORTED ON THE PATIENT WAS ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22787764 ↗InjuryJul 21, 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 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. TOOTH #11. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22556395 ↗InjuryJun 25, 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. PER INDICATED: IMPLANTS SHOWED EARLY SIGNS OF PERIIMPLANTITIS, TOOTH SITE: 9. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22332850 ↗InjuryJun 25, 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 #6 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22331506 ↗InjuryJun 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 #9 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22226829 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 46 WAS REMOVED DUE TO PERI-IMPLANTITIS.PAIN REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21750201 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #32 #42 AND #44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED. THE DOCTOR REPORTED INFLAMMATION AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21570677 ↗InjuryNov 22, 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: Pain
MAUDE report 20761191 ↗InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS GIVEN CLINDAMYCIN, 150MG FOR SEVEN DAYS FOR INFECTION TO TRY TO KEEP THE IMPLANT BEFORE THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EDEMA.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20725394 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED BONE LOSS ON TOOTH 11 (UNIVERSAL). THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 19293427 ↗InjuryMay 8, 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 #20 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19272874 ↗InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENT FOR POST OP VISIT. PUS WAS FOUND AND PATIENT WAS IN PAIN. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 19161041 ↗InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REMOVED THE IMPLANT FOLLOWING A RECURRENT VESTIBULAR INFECTION. PROCEDURE COMPLETED. TOOT LOCATION: 24. ABSCESS AND PAIN WERE REPORTED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19104745 ↗InjuryNov 29, 2023Adverse 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. TOOTH SITE # 15.SITE GRAFTED AT TIME OF IMPLANT PLACEMENT WITH ALLOGRAFT AND CORTICAL GENET BLEND.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18232596 ↗InjuryNov 29, 2023Adverse 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18228708 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR THEIR ONE (1 ) MONTH POST OP VISIT. PUS WAS FOUND AROUND THE IMPLANT AT TOOTH LOCATION #5 AND THE PATIENT WAS IN PAIN. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Pain; Purulent Discharge; Unspecified Infection
MAUDE report 17949264 ↗InjurySep 22, 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: Nerve Damage
MAUDE report 17797899 ↗InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 9 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 17557309 ↗InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT IMPLANT TOOTH SITE #3. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 17491705 ↗InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE, INFECTION AND TENDERNESS WAS FOUND AT THE REGION AROUND THE IMPLANT AT TOOTH LOCATION #11. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 16619279 ↗InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATION 31 WERE REMOVED DUE TO INFECTION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 16361649 ↗InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO INFECTION. INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 16334578 ↗InjuryJan 31, 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 16272799 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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