Tapered Screw-Vent® TSVMWB10Recalls & 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 is a dental implant placed in the jawbone. Its 217 reports mostly describe infection and inflammation around the implant, often leading to its removal, and bone loss around the implant. The reports include 192 injuries and no deaths. 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
- 218
- Deaths reported
- 0
- Injuries reported
- 193
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 00889024019775), received between Feb 27, 2020 and Sep 18, 2026 — classified as 193 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Fracture” (30 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 Problem166
- Fracture30
- Mechanical Problem14
- Component Missing3
- Patient-Device Incompatibility3
- Separation Failure3
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection122
- Osteolysis68
- Inflammation62
- No Clinical Signs, Symptoms or Conditions52
- Pain42
- Discomfort11
- No Information11
- Abscess8
Recent adverse event reports
The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to an infection at tooth site 19. Tenderness on the area.Bone density type: II.
Patient problems: Unspecified Infection
MAUDE report 50815715 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant a tooth site #30 was removed due to bone loss.
Patient problems: Osteolysis
MAUDE report 50096418 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UPON EXAM, THERE WAS INFECTION AND TENDERNESS AROUND THE REGION OF THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 25448965 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THERE WERE INFECTION AND TENDERNESS AROUND THE IMPLANT AT TOOTH SITE #18. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 25399639 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THERE WAS TENDERNESS AND INFECTION AROUND THE REGION OF THE IMPLANT AT TOOTH SITE #13. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25299013 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THERE WAS TENDERNESS AT THE REGION AROUND THE IMPLANT AT TOOTH SITE #30. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Discomfort; Inflammation; Unspecified Infection
MAUDE report 25285242 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT POST OP, THE IMPLANT IN SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. ANOTHER IMPLANT WAS PLACED TO COMPLETE PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25278320 ↗MalfunctionMay 19, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS NOT PLACED AS THE PACKAGING WAS NOT SEALED PROPERLY. PACKAGE IS NOT PROPERLY SEALED. THE OUTER PART OF THE PACKAGING IS NOT SEALED PROPERLY (THE LEAD IS NOT TIGHTLY CLOSED AND THE LOCK (THE NOTCHES ON THE BOX) APPEARS TO HAVE BEEN DEFECTIVE. I DISCOVERED IT TODAY DURING IMPLANT PLACEMENT. I DO NOT FEEL COMFORTABLE PLACING THIS IMPLANT AS NOT ALL PACKAGING IS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221858 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THERE WAS TENDERNESS AND INFECTION AT THE REGION AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25216297 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 31 WAS REMOVED DUE TO BONE LOSS. SITE WAS BONE GRAFTED AND PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. GRAFTED PRIOR TO IMPLANT PLACEMENT. NOTED PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25209148 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT CAME TO CLINICIAN FOR A CHECK-UP REFERRING DISCOMFORT IN THE ZONE. DOCTOR NOTICED BONE LOSS AND A SMALL ZONE AFFECTED BY PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 25147119 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 31 WAS REMOVED DUE TO INFECTION. HAD AN INFECTION ON EXAM. HAD TENDERNESS AT REGION. NOTED INFLAMMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Unspecified Infection
MAUDE report 25122860 ↗InjuryApr 14, 2026Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Pain
MAUDE report 24869506 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO BONE LOSS + INFECTION. PATIENT EXPERIENCED PAIN, ABSCESS AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24679391 ↗MalfunctionFeb 23, 2026Separation Failure
IT WAS REPORTED THAT THE MOUNT WOULD NOT DISENGAGE FROM THE IMPLANT AT TOOTH SITE #31 DURING A CLINICAL PROCEDURE. IT WAS REMOVED USING TWO SETS OF PLIERS. THE PROCEDURE WAS COMPLETED USING A NEW IMPLANT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421832 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT AT TOOTH SITE #26 HAD LACK OF PRIMARY STABILITY DUE TO A SINUS PERFORATION. THE IMPLANT WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257444 ↗MalfunctionFeb 4, 2026Fracture
DOCTOR REPORTED THAT DURING PROCEDURE THE HEX FROM MOUNT FRACTURED INSIDE THE IMPLANT AT TOOTH SITE 36. THE FRACTURED PART COULD BE REMOVED FROM IMPLANT WITHOUT CAUSING ANY DAMAGE. THERE WAS A DELAY IN THE PROCEDURE DUE TO HEX REMOVAL, ENDOSCOPIC ULTRASOUND TIP WAS USED UNDER SURGICAL MICROSCOPE. IMPLANT REMAINS IMPLANTED, ONLY MOUNT WAS RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256024 ↗MalfunctionJan 29, 2026Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215222 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 24115656 ↗MalfunctionJan 5, 2026Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960311 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23950768 ↗InjuryDec 19, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, EDEMA AND ABSCESS.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23850137 ↗InjuryDec 17, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830259 ↗InjuryDec 5, 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 23726640 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THE IMPLANT AT TOOTH SITE #3 SHOWED TENDERNESS AND INFECTION AT THE REGION. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23687128 ↗
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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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