Tapered Screw-Vent® TSVTWB8Recalls & 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 has 263 adverse event reports, including 244 injuries, 19 malfunctions and no deaths. Reports mostly describe bone loss and infection around the implant, often leading to its removal, and some describe fractures or implants that became loose. There are no recalls that 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
- 260
- Deaths reported
- 0
- Injuries reported
- 241
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00889024020030), received between Oct 4, 2019 and May 19, 2026 — classified as 241 injuries, 19 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 Problem224
- Fracture18
- Separation Failure9
- Mechanical Problem5
- Component Missing4
- Loss of Osseointegration3
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection135
- Osteolysis118
- Inflammation50
- Pain49
- No Clinical Signs, Symptoms or Conditions46
- No Information18
- Abscess10
- Swelling/ Edema9
Recent adverse event reports
The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT BECAME INFECTED FAILING TO INTEGRATE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25215940 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS CAUSING A LOOSE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Osteolysis; Pain; Swelling/ Edema
MAUDE report 24957719 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT LOST THE IMPLANT AT TOOTH SITE #28 AFTER IT BECAME LOOSE DUE TO BONE LOSS. THIS WAS RELATED TO AN IMPLANT OVERDENTURE.
Patient problems: Osteolysis
MAUDE report 24943930 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS. PLACED IMPLANT IN 2024. SEVERE BONE LOSS IN IMPLANT AREA. BECAME LOOSE WENT TO REMOVE CROWN AND THE IMPLANT CAME OUT, ON (B)(6) 2026. PATIENT WILL HEAL AND RETURN TO GET A REPLACEMENT
Patient problems: Osteolysis
MAUDE report 24673596 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 FAILED DUE TO BONE LOSS AND WAS REMOVED. THE SITE WAS GRAFTED AND AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE ZIMMER IMPLANT.
Patient problems: Osteolysis
MAUDE report 24651865 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24626145 ↗InjuryMar 17, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616019 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. SITE UNKNOWN BECAME INFECTED FAILING TO INTEGRATE. WILL ALLOW SITE TO HEAL TRADITIONALLY AND RE-ATTEMPT IN 2-3 MONTHS. NOTED INFLAMMATION AND INFECTION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24558970 ↗InjuryMar 5, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524248 ↗InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT DURING AN X-RAY EXAM, THE IMPLANT PLATFORM AT TOOTH SITE #13 WAS NOTED TO BE FRACTURED. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524183 ↗InjuryFeb 25, 2026Adverse 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 24441436 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24305245 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT BECAME INFECTED, AND HAD FAILED TO INTEGRATE. THE SITE WILL BE ALLOWED TO HEAL TRADITIONALLY AND AN IMPLANT REPLACEMENT WILL BE ATTEMPTED IN TWO OR THREE MONTHS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24118449 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23992183 ↗InjuryDec 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 #2 WAS REMOVED DUE TO BONE LOSS. BONE LOSS AT APEX OF IMPLANT OBSERVED AT FINAL POST-OP VISIT.
Patient problems: Osteolysis
MAUDE report 23780899 ↗InjuryDec 4, 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
MAUDE report 23716014 ↗InjuryDec 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 PERI-IMPLANTITIS. BUCCAL AND MESIAL BONE LOSS DISCOVERED UNDER IMPLANT SUPPORTED BRIDGE SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23689484 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #17 WAS REMOVED DUE TO INFECTION. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 23678780 ↗InjuryNov 20, 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 #18 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23604349 ↗InjuryNov 17, 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: Unspecified Infection
MAUDE report 23568372 ↗InjuryNov 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER EIGHT YEARS, THE IMPLANT AT TOOTH SITE #4 FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23565666 ↗InjuryNov 14, 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23560044 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT THE FINAL CHECK APPOINTMENT, A FISTULA WAS PRESENT ON THE LINGUAL OF THE IMPLANT AT TOOTH SITE #14. ACTIVE DRAINAGE WITH COMPRESSION WAS ALSO NOTED. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Fistula; Purulent Discharge; Unspecified Infection
MAUDE report 23487059 ↗InjuryOct 31, 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. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23442238 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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