Tapered Screw-Vent® TSVTWB11Recalls & 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 placed in the jawbone. Its 328 reports describe implants that were removed after infection, peri-implantitis, bone loss, or fracture, and some mention pain. The reports include no deaths and 301 injuries. No recalls name this device. Reports fell to 34 in the last 12 months from 57 in the 12 months before.
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
- 326
- Deaths reported
- 0
- Injuries reported
- 299
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 326 adverse event reports that list this exact device (DI 00889024020009), received between Oct 31, 2019 and Sep 10, 2026 — classified as 299 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Fracture” (79 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 Problem219
- Fracture79
- Mechanical Problem13
- Separation Failure8
- Component Missing7
- Failure to Osseointegrate2
- Loss of Osseointegration2
- Device Damaged by Another Device1
Patient problems
- Unspecified Infection145
- Osteolysis110
- No Clinical Signs, Symptoms or Conditions94
- Pain71
- Inflammation59
- No Information21
- Abscess18
- Erosion11
Recent adverse event reports
The 25 most recent of 326 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant was removed due to an infection, tooth site 19. Patient presented to the clinic with pain.
Patient problems: Pain; Unspecified Infection
MAUDE report 50714021 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
During the clinical visit, the patient presented with a loose implant. The implant was determined to have failed due to peri-implantitis and was successfully removed. No harm to the patient was reported.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50295805 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant lost bone support due to peri implantitis and became mobile. Implant was removed. Tooth site 30.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50096669 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. SLOWLY ADVANCING BONE LOSS AND MOBILITY. TOOTH NUMBER 19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25479577 ↗InjuryMay 18, 2026Fracture
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO FRACTURED COLLAR. IMPLANT WAS RETURNED WITH A FRACTURED ZIMMER SCREW INSIDE. REMOVAL / BONE GRAFT / NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25204281 ↗MalfunctionMay 6, 2026Component Missing
IT WAS REPORTED THAT THE DOCTOR WENT TO OPEN AN IMPLANT DURING A PROCEDURE AND THE IMPLANT PACKAGE WAS EMPTY. THE INNER VIAL WAS INSIDE BUT EMPTY. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104669 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE GENERAL DENTIST OFFICE AND THE DENTIST NOTICED BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #19. THE GENERAL DENTIST REFERRED THEM BACK TO OUR OFFICE TO HAVE THE IMPLANT REMOVED.
Patient problems: Osteolysis
MAUDE report 25083158 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED COMPLAINING OF PAIN, SWELLING AND DISCOMFORT AFTER ONE MONTH AT THE IMPLANT AT TOOTH SITE #29. THE CLINICIAN PERFORMED A DEBRIDEMENT PROCEDURE AND THE IMPLANT WAS REMOVED. GRANULATED TISSUE ON THE FACIAL LOCATION OF THE IMPLANT WAS DISCOVERED AND THE IMPLANT AND WAS REMOVED. THE TOOTH SITE WAS GRAFTED WITH AN IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Osteolysis
MAUDE report 24987996 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE PATIENT HAD SWELLING AND SENSITIVITY IN THE AREA. A CURETTAGE PROCEDURE WAS PERFORMED. IT WAS OPTED TO WAIT THREE MONTHS FOR THE SITE TO HEAL. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24781827 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24758271 ↗InjuryMar 30, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717085 ↗InjuryMar 23, 2026Fracture
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO FRACTURED IMPLANT. PATIENT PRESENTED WITH FRACTURED IMPLANT PLATFORM EVIDENT ON PERIAPICAL RADIOGRAPH. TOOTH NUMBER 19.SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation
MAUDE report 24661174 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REPORTED PAIN STARTING DAY ONE (1) OF PLACEMENT OF THE IMPLANT AT TOOTH SITE #30 AND LITTLE RELIEF OVER A TWO-WEEK PERIOD. FISTULA FOUND ON FOLLOW UP. AREA EXPLORED WITH INFLAMMATION AND BONE RESORPTION. THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24643165 ↗MalfunctionMar 16, 2026Fracture
IT WAS REPORTED THAT THE MOUNT HEX FRACTURED INTO THE IMPLANT AT TOOTH SITE #19, AND THE DOCTOR COULD NOT GET THE HEX OUT. THEY HAD TO CHANGE THE SIZE OF THE IMPLANT, AND THE NEW IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604435 ↗InjuryMar 2, 2026Adverse 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 24482668 ↗InjuryFeb 25, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442809 ↗InjuryFeb 19, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389021 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. IMPLANT #30 WITH OSTEOLYSIS AROUND IMPLANT, FAILED AGAIN. REPLACED WITH TSX SAME SIZE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24317460 ↗MalfunctionFeb 10, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307719 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS, INFECTION. PATIENT REPORTED TO CLINIC FOR EXTRACTION OF MOLAR. DURING PROCEDURE, IT WAS NOTED THAT IMPLANT CROWN #30 WAS MOBILE. CROWN REMOVED TO INSPECT IMPLANT. UPON INSPECTION, BONE LOSS AND INFECTION WERE FOUND. IMPLANT #30 REMOVED, AREA DEBRIDED, GRAFT PLACED WITH MEMBRANE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24201835 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Osteolysis
MAUDE report 24079821 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD BUBBLE AROUND IMPLANT SITE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23981440 ↗InjuryDec 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 #31 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23858919 ↗InjuryDec 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 #19 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23829706 ↗InjuryDec 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 #19 WAS REMOVED DUE TO BONE LOSS. AT TIME OF SURGICAL EXPLORATION, DEBRIDEMENT TO PERSISTENT FISTULA, NOTED GRANULATION TISSUE AROUND IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Fistula; Inflammation; Osteolysis
MAUDE report 23761398 ↗
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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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