Tapered Screw-Vent® TSVMB13Recalls & 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 root-form implant placed in the jawbone. Its 92 reports, with 91 injuries and no deaths, mostly describe infection, bone loss and inflammation around the implant, called peri-implantitis, with some implants removed, and some describe abscess and pain. No recalls name this device. Reports for the last 12 months (8) are fewer than in the previous 12 months (21).
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
- 92
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00889024019744), received between Aug 20, 2019 and Apr 1, 2026 — classified as 91 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (4 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 Problem86
- Fracture4
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Unspecified Infection64
- Osteolysis40
- Inflammation27
- Pain21
- No Clinical Signs, Symptoms or Conditions10
- Abscess7
- No Code Available5
- Swelling/ Edema5
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24758453 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS REMOVED DUE TO INFECTION AND TENDERNESS AT THE REGION. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24575901 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE GENERAL DENTIST WITH COMPLAINTS OF PAIN. THE PATIENT WAS REFERRED FROM THE GENERAL DENTIST. X-RAY IMAGING WAS PERFORMED AND CONFIRMED BONE LOSS. THE IMPLANTS AT TOOTH SITES #20 AND #21 WERE REMOVED.
Patient problems: Osteolysis; Pain
MAUDE report 24405560 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND #14 WERE REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. ADDITIONAL APPOINTMENTS WERE ANTICIPATED TO REPLACE THE IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 24262088 ↗InjuryDec 22, 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 INFECTION AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23871315 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AROUND TOOTH SITE #29. IMPLANT WAS REMOVED. NO OTHER IMPACT ON THE PATIENT REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23736196 ↗MalfunctionDec 2, 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 23694087 ↗InjuryDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689426 ↗InjuryOct 28, 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; Unspecified Infection
MAUDE report 23407172 ↗InjuryOct 21, 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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD DISCOMFORT AND PAIN.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 23348106 ↗InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #29 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22577546 ↗InjuryJul 22, 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. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WAS REMOVED., TOOTH 10. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22564999 ↗InjuryJul 18, 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 #10, #20 AND #22 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22546275 ↗InjuryJun 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 SHOWED EARLY SIGNS OF PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22324778 ↗InjuryJun 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 SHOWED EARLY SIGNS OF PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22324729 ↗InjuryJun 22, 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22304578 ↗InjuryJun 16, 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 #23 AND #26 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22214973 ↗InjuryJun 16, 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 #23 AND #26 SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22214947 ↗InjuryJun 16, 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 #25 SHOWED EARLY SIGNS OF PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22214830 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO INFECTION AND WERE REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Pain; Unspecified Infection
MAUDE report 22024447 ↗InjuryApr 28, 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 21919036 ↗InjuryJan 27, 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 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21246667 ↗InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 13 WAS REMOVED DUE TO INFECTION. PATIENT REFERRED STRONG INCREASING OF PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 21207270 ↗InjuryDec 26, 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 #9 WAS REMOVED DUE TO INFECTION & BONE LOSS. SOME PAIN IN THE GUMS WAS ALSO REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21020997 ↗InjuryDec 19, 2024Adverse 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; Nerve Damage; Unspecified Infection
MAUDE report 20976816 ↗
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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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