Tapered Screw-Vent® TSVMB11Recalls & 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 to hold a tooth replacement. Its 155 reports mostly describe infection and bone loss around the implant, with implants sometimes removed, and some report breaking or damage during placement. The reports include no deaths and 141 injuries, and 14 are malfunctions. 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
- 158
- Deaths reported
- 0
- Injuries reported
- 144
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00889024019737), received between Oct 18, 2019 and Sep 14, 2026 — classified as 144 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (21 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 Problem121
- Fracture21
- Component Missing4
- Mechanical Problem4
- Separation Failure4
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Packaging Problem1
Patient problems
- Unspecified Infection98
- Osteolysis67
- No Clinical Signs, Symptoms or Conditions41
- Inflammation37
- Pain30
- No Information6
- Swelling/ Edema6
- Abscess3
Recent adverse event reports
The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #28 was removed due to infection. The patient experienced inflammation and tenderness.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50750318 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50647394 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50647309 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to peri-implantitis. Tooth site 23.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50017639 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. INFECTION ON EXAM #9 AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25479317 ↗InjuryMay 14, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25171451 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fistula; Osteolysis; Unspecified Infection
MAUDE report 24938137 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24899947 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TENDERNESS WAS NOTED AT THE IMPLANT AT TOOTH SITE #27. THE IMPLANT WAS REMOVED DUE TO INFECTION. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24746107 ↗MalfunctionMar 30, 2026Mechanical Problem
DOCTOR REPORTS WHEN PLACING THE IMPLANT AT TOOTH SITE 36, A DAMAGE TO THE CONNECTION WAS DETECTED AND, WHEN TRYING TO REMOVE IT, IT WAS DIFFICULT TO DISENGAGE THE EXTRACTOR. THEY HAD TO DRILL AROUND THE IMPLANT TO FINALLY REMOVE IT. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24726903 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REPLACED DURING THE SAME PROCEDURE. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24697957 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO TENDERNESS AND INFECTION. AN ADDITIONAL PROCEDURE WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24592455 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 32 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANTS WERE PLACED DURING THE SAME PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24434227 ↗InjuryFeb 19, 2026Fracture; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT HEAD WAS DAMAGED, PREVENTING PROPER ENGAGEMENT OF THE MOUNT AND THE IMPLANT WAS REMOVED. PROCEDURE NOT COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388252 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #35 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24370295 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24339405 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 22 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24308997 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS INFECTION WITH TENDERNESS AT THE REGION AROUND THE IMPLANTS AT TOOTH SITES #12 AND #13. THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24245537 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS INFECTION WITH TENDERNESS AT THE REGION AROUND THE IMPLANTS AT TOOTH SITES #12 AND #13. THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24245454 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD MEDICAL APPOINTMENT TO CREATE A BRIDGE 43-46, IMPLANT TOOTH LOCATION #44, HAD PERI-IMPLANTITIS SIGNS. PERI-IMPLANTITIS PROTOCOL FOLLOWED AND LEFT IN OBSERVATION. WHEN PATIENT CAME TO PLACE THE BRIDGE, WHEN UNSCREWING THE PROVISIONAL THE IMPLANT #44 CAME OUT. NEW IMPLANT WOULD BE PLACED AFTER BONE REGENERATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24027286 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23976900 ↗MalfunctionDec 30, 2025Device Damaged by Another Device; Device Damaged by Another Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920526 ↗InjuryDec 30, 2025Adverse 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920447 ↗InjuryDec 13, 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: Osteolysis
MAUDE report 23797712 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO (2) IMPLANTS FAILED THE TORQUE TEST AND CAME OUT DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. TOOTH SITES ARE UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23694069 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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- 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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