Tapered Screw-Vent® TSVT6B11Recalls & 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 has 110 adverse event reports, with no deaths and 105 injuries. Many reports describe the implant being removed after a gum infection or bone loss around it, with pain and swelling. Reports fell to 3 in the last 12 months from 21 in the 12 months before. 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
- 111
- Deaths reported
- 0
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00889024019881), received between Aug 20, 2019 and Sep 8, 2026 — classified as 106 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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 Problem94
- Fracture11
- Component Missing2
- Loss of Osseointegration2
- Mechanical Problem2
- Detachment of Device or Device Component1
- Malposition of Device1
- Separation Failure1
Patient problems
- Unspecified Infection59
- Osteolysis52
- Pain28
- Inflammation16
- No Clinical Signs, Symptoms or Conditions15
- No Code Available7
- No Information7
- Abscess4
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported, after follow up, that due to an infection, it was not the best choice to place the sterile implant into the site and the implant was removed 1 day after implantation. Tooth site 19.
Patient problems: Unspecified Infection
MAUDE report 50668870 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TOLD TWO (2) YEARS AGO THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #14 BUT THE PATIENT DID NOT FOLLOW UP. THE IMPLANT HAD AVULSED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25217408 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT SHOWED SIGNS OF INFECTION WITH PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24402315 ↗InjuryFeb 12, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326946 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE, THE PATIENT WAS HAVING SIGNIFICANT DISCOMFORT AND SWELLING IN THE AREA OF THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23348904 ↗InjurySep 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 #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 23098923 ↗InjurySep 15, 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: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23057225 ↗InjuryAug 23, 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT PRESENTED FOR REGULAR HYGIENE APPOINTMENT AND IT WAS NOTED THAT THERE WAS SEVERE BONE LOSS WITH THE IMPLANT SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: YES. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, GRAFT CHECK/RE-IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22880288 ↗InjuryAug 8, 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: Discomfort; Pain
MAUDE report 22755523 ↗InjuryJul 21, 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 #30 WAS REMOVED DUE TO SEVERE BONE LOSS. DEBRIDED, PLAN TO REPLACE IMPLANT IN 4-6 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22553455 ↗InjuryJun 26, 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. SEVERE PERI-IMPLANTITIS NOTICED IN (B)(6) 2024. LASER THERAPY WAS DONE ON THE IMPLANT ON (B)(6) 2024. LASER THERAPY WAS NOT SUCCESSFUL.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22336622 ↗InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS GIVEN LASER THERAPY BEFORE THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306863 ↗InjuryJun 16, 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: Pain
MAUDE report 22210198 ↗InjuryJun 3, 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 #3 WAS REMOVED DUE TO MEDICAL INFECTION. ON EXAMINATION, THE PATIENT HAD HEAVY PLAQUE ACCUMULATION AND THE BUCCAL GINGIVA WAS ERYTHEMATOUS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, SWELLING AND PAIN.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 22134613 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THE LOOSE IMPLANT WITH BONE LOSS. THE IMPLANT WAS REMOVED. GRAFTED: ALLOGRAFT. TOOTH SITE: 30.
Patient problems: Osteolysis
MAUDE report 22025059 ↗InjuryApr 30, 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 21933132 ↗InjuryApr 30, 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 21932889 ↗MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT IMPLANT FELL OFF MOUNT DURING LOADING. HE IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH SITE: 31.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861332 ↗InjuryMar 18, 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21634498 ↗InjuryMar 13, 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 21599408 ↗InjuryFeb 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT; INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21360990 ↗InjuryFeb 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21358648 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #13 AND #14 HAD EXTENSIVE BONE LOSS AND WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 21161794 ↗InjuryNov 19, 2024Adverse 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: Unspecified Infection
MAUDE report 20728492 ↗InjuryNov 14, 2024Adverse 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; Unspecified Infection
MAUDE report 20689358 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page