Tapered Screw-Vent® TSV4B8Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent dental implant is placed into bone. Its 256 reports often describe infection around the implant and bone loss, with some implants removed, and some mention fractures and missing components. There were no deaths and 240 injuries, and reports fell to 22 in the last 12 months from 52 in the 12 months before. 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
- 258
- Deaths reported
- 0
- Injuries reported
- 242
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00889024019263), received between Sep 17, 2019 and Sep 9, 2026 — classified as 242 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem226
- Fracture18
- Component Missing6
- Patient-Device Incompatibility3
- Mechanical Problem2
- Separation Failure2
- Failure to Osseointegrate1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection172
- Osteolysis139
- Pain65
- Inflammation51
- No Clinical Signs, Symptoms or Conditions37
- No Information14
- Abscess13
- Swelling/ Edema12
Recent adverse event reports
The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that doctor followed the TSV surgical procedures to place the implant - TSV4B8 at tooth site 26. After 3 weeks, infection was happened to the patient.
Patient problems: Unspecified Infection
MAUDE report 50690061 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented for a follow-up visit with suppuration at the implant site 16. A significant infection was observed, compromising the stability of the implant and the implant was removed.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 50067177 ↗MalfunctionMay 20, 2026Separation Failure
IT WAS REPORTED THAT THE MOUNT WAS STUCK TO THE IMPLANT AND COULD NOT BE REMOVED. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233419 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 25176116 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO AN INFECTION AND A COMPLETE PERI-IMPLANT BONE LOSS EXTENDING UP TO THE SINUS FLOOR. PATIENT SUFFERED FROM ABSCESS AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25134698 ↗InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #47. IMPLANT WAS REMOVED. NO OTHER IMPACT ON THE PATIENT REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24919732 ↗InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #46. IMPLANT WAS REMOVED. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24919671 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24834608 ↗MalfunctionMar 30, 2026Fracture
THE DOCTOR REPORTS THAT THE CONNECTION OF THE GREEN MOUNT BROKE AND THAT THE FRACTURED FRAGMENT REMAINED STUCK IN THE IMPLANT AND THE IMPLANT WAS REMOVED. THE DOCTOR DID NOT REPORT ANY IMPACT ON THE PATIENT¿S HEALTH AS A CONSEQUENCE OF THE EVENT AND CONFIRMED IN THE FORM THAT THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728363 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO BONE LOSS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: Osteolysis
MAUDE report 24725422 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 44 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24501381 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #13 AND #23 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24457851 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO INFECTION. THE PATIENT HAD RETURNED WITH PAIN AND AN ABSCESS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 24367792 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. #14 IMPLANT WAS LOOSE AND HAD DEVELOPED OF SOFT TISSUE AROUND CREST. FAILURE TO INTEGRATE; REMOVED AND REPLACED 4 MONTHS LATER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24317156 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #32 AND #34 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24152610 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 47 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23950253 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 46 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23950189 ↗InjuryDec 18, 2025Adverse 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; Pain; Unspecified Infection
MAUDE report 23843722 ↗InjuryDec 12, 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 #36 WAS REMOVED DURING SECOND SURGERY DUE TO PERI-IMPLANTITIS WITH ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23791646 ↗InjuryDec 3, 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 #37 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23707758 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM ABSCESS, PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23702844 ↗InjuryNov 25, 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 #36 AND #46 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23645810 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23585974 ↗InjuryNov 7, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23501127 ↗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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23439821 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page