Tapered Screw-Vent® TSVT4B10Recalls & 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 to hold a replacement tooth. Of its 354 reports, 322 describe injuries and 32 describe malfunctions, with no deaths. Many describe infection, bone loss around the implant, pain or inflammation, and some describe the implant fracturing. 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
- 363
- Deaths reported
- 0
- Injuries reported
- 331
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 363 adverse event reports that list this exact device (DI 00889024019829), received between Sep 4, 2018 and Sep 29, 2026 — classified as 331 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Fracture” (42 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 Problem290
- Fracture42
- Separation Failure13
- Component Missing9
- Mechanical Problem5
- Patient-Device Incompatibility2
- Separation Problem2
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection178
- Osteolysis156
- No Clinical Signs, Symptoms or Conditions86
- Pain84
- Inflammation59
- No Information26
- Abscess15
- Swelling/ Edema12
Recent adverse event reports
The 25 most recent of 363 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929730 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Due to the extent of bone loss and infection, the implants at sites #8, #10, #11, and #12 were removed. Patienet referred pain. Antibiotic superscripted.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50751305 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Due to the extent of bone loss and infection, the implants at sites #8, #10, #11, and #12 were removed. Patienet referred pain. Antibiotic superscripted.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50751304 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Due to the extent of bone loss and infection, the implants at sites #8, #10, #11, and #12 were removed. Patient referred pain. Antibiotic superscripted.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50751302 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Due to the extent of bone loss and infection, the implants at sites #8, #10, #11, and #12 were removed. Patienet referred pain. Antibiotic superscripted.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50751301 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implants were removed due to peri-implantitis at tooth site 15. The patient experienced an abscess accompanied by pain, edema, and significant inflammation.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50750720 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6), 2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50712145 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6) 2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50711850 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6) 2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50711652 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6)2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50711562 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6) 2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50711448 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, the implants at sites #8, #10, #12, #13, #14, and #15 were removed. The patient reported pain. Antibiotics were prescribed on (b)(6) 2026.
Patient problems: Pain; Unspecified Infection
MAUDE report 50711348 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient went to the clinic for a post op appointment due to pain. Implant at tooth site 21 was removed due to peri-implantitis. SIte was grafted and will return in six months. Inflammation, Pain and Swelling reported as a consequence..
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50080829 ↗InjuryJun 4, 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 25399012 ↗MalfunctionJun 1, 2026Component Missing
IT WAS REPORTED THAT THE CLINICIAN OPENED IMPLANT AND VIAL WAS EMPTY. CLINICIAN OPENED A NEW IMPLANT AND FINISHED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351495 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RADIOLUCENCY AROUND THE APEX OF IMPLANT AT TOOTH SITE #3. THIS WAS CONFIRMED DURING A ROUTINE HYGIENE EXAM. THE IMPLANT WAS REMOVED AND THE BONE AND TISSUE WERE GRAFTED. AFTERWARDS AN ATTEMPT WAS MADE TO DEBRIDE THE AFFECTED AREA. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24998451 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRAIRATIC PROGRESSIVE BONE LOSS WAS NOTED AT THE IMPLANTS AT TOOTH SITES #19, #20 AND #21 AND WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 24769932 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. THE PATIENT PRESENTED WITH PAIN AND SWELLING IN THE AREA. FOLLOWING THE REMOVAL PROCEDURE, THE CUSTOMER OPTED TO ALLOW THE PATIENT TO HEAL PRIOR TO PLACING A REPLACEMENT IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24690524 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24621130 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24604293 ↗MalfunctionMar 2, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490363 ↗InjuryMar 2, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24485551 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED AS IT WAS INFECTED. PT SEEN FOR EMERGENCY OFFICE VISIT. UPPER DENTURE FRACTURED AT #10. REMOVED DENTURE 11-14 WITH IMPLANT ATTACHED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA & INFLAMMATION.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24468969 ↗MalfunctionFeb 20, 2026Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404750 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT PLACED 2018, UNDER PREPPED TO ACHIEVE STABILITY IN SOFT BONE. PART OF MAX OVERDENTURE (BAR RETAINED), POOR PATIENT COMPLIANCE, LATER CONVERTED TO LOCATOR ATTACHMENTS (RESTORED BY GENERAL DDS). SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24349764 ↗
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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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