Tapered Screw-Vent® TSVB16Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent is a root-form dental implant placed in the jawbone. Its 98 adverse event reports include no deaths, 75 injuries and 23 malfunctions. The reports mostly describe infection and bone loss around the implant, with some implants removed, and some describe packaging that was not sealed. 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
- 99
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00889024019539), received between Jan 15, 2020 and Sep 9, 2026 — classified as 76 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (20 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem75
- Unsealed Device Packaging20
- Component Missing2
- Fracture1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Unspecified Infection53
- Osteolysis41
- No Clinical Signs, Symptoms or Conditions27
- Pain20
- Inflammation12
- No Information10
- Abscess4
- Erosion4
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with Grade II mobility of an IS bridge. Radiographic examination revealed significant bone loss. Clinical examination showed exposure of the implant threads. The patient was diagnosed with peri-implantitis. It was decided to remove the implants in order to perform guided bone regeneration (GBR) and subsequently place new implants. Tooth sites 11, 13, 22 and 23.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50690685 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED UPDATING THE IMPLANT PLACEMENT DATE.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25322937 ↗InjuryMay 28, 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 25321753 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 23 & 24 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED BY PLACING OTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25175480 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24568720 ↗InjuryDec 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 #24 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Pain
MAUDE report 23783246 ↗InjuryNov 18, 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; Unspecified Infection
MAUDE report 23586718 ↗InjuryNov 18, 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; Unspecified Infection
MAUDE report 23586536 ↗InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WITH INFECTION ON IMPLANT. TOOTH SITE # 23.
Patient problems: Unspecified Infection
MAUDE report 23531223 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION, TOOTH SITE # 26.
Patient problems: Unspecified Infection
MAUDE report 23526573 ↗InjuryOct 31, 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: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23442056 ↗InjuryOct 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; Pain; Unspecified Infection
MAUDE report 23300382 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BONE LOSS AND INFECTION AROUND THE IMPLANT AT TOOTH SITE # 21 (FDI). THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23088867 ↗InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BONE LOSS AND INFECTION AT TOOTH SITE # 16. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22880259 ↗InjuryAug 11, 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: Unspecified Infection
MAUDE report 22779276 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #11 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22725282 ↗InjuryAug 1, 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 #9 WAS REMOVED DUE TO LOSS OF INTEGRATION ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22690280 ↗InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #43. SYMPTOMS REPORTED ON THE PATIENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22505502 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PAIN AND INFLAMMATION DUE TO PERI-IMPLANTITIS, IMPLANT #21 HAS BEEN REMOVED. PROCEDURE NOT COMPLETED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21310733 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #23 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20732072 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 44, 43, 33 WERE REMOVED DUE TO PERI-IMPLANTITIS. A NEW IMPLANT WAS PLACED AT TOOTH SITE 44. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20598415 ↗InjurySep 26, 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 20315738 ↗InjuryJul 18, 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 19772409 ↗InjuryJun 26, 2024Adverse 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; Pain; Unspecified Infection
MAUDE report 19620737 ↗InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE COMPLETED USING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19526429 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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