Tapered Screw-Vent® TSVH16Recalls & 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 jaw to hold a tooth replacement. Reports mostly describe infections around the implant with bone loss, loosening, and removal, plus pain and numbness in some cases. There are 23 reports that name its identifier, with 23 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024019591), received between Apr 3, 2020 and Sep 29, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Fracture” (3 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 Problem21
- Fracture3
- Loss of Osseointegration1
Patient problems
- Unspecified Infection14
- Osteolysis12
- No Clinical Signs, Symptoms or Conditions5
- Pain4
- Abscess2
- Inflammation2
- No Code Available2
- No Information2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50930036 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC COMPLAINING OF NUMBNESS ON THE LOWER RIGHT AREA OF THE IMPLANT AT TOOTH SITE #28. THE IMPLANT WAS REMOVED DUE TO NERVE DAMAGE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND NUMBNESS.
Patient problems: Numbness; Pain
MAUDE report 24377119 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 LOST INTEGRATION AND CAME OUT DUE TO PERI-IMPLANTITIS. THE PATIENT CAME IN WITH THE IMPLANT OUT OF THE MOUTH.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24161557 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT AT TOOTH SITE #11 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23090468 ↗InjuryAug 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 #7 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 22775010 ↗InjuryJul 8, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 22434405 ↗InjuryAug 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; Unspecified Infection
MAUDE report 20067706 ↗InjuryMay 7, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260950 ↗InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS FACIALLY AT IMPLANT TOOTH SITE #24. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 17932667 ↗InjurySep 14, 2023Fracture; Fracture
IT WAS REPORTED THE PATIENT EXPERIENCED AN IMPLANT FRACTURED AT TOOTH #6 WHEN THE DENTIST WAS TIGHTENING THE CROWN. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17742245 ↗InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MESIAL ASPECT OF THE IMPLANT AT TOOTH LOCATION #11 EXHIBITED BONE LOSS EXTENDING TO #10. THE IMPLANT AT TOOTH LOCATION #11 WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 17564005 ↗InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17549952 ↗InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT PRESENTED WITH EXUDATE PRESENT AT IMPLANT # 12. XRAY REVEALS INFECTION AND BONE LOSS. IMPLANT REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17282815 ↗InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 (UNIVERSAL) EXPERIENCED AN INFECTION AND WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 13451035 ↗InjuryOct 28, 2021Adverse 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 WITH A LOSS OF INTEGRATION, INFECTION, BONE LOSS, AN ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Inadequate Osseointegration; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12711963 ↗InjurySep 20, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED. THE SITE WAS GRAFTED. TOOTH LOCATION UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12502387 ↗InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED. THE SITE WAS GRAFTED. TOOTH LOCATION UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12502373 ↗InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 27 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT ARE ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12298189 ↗InjuryJun 29, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12086075 ↗InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT DID NOT INTEGRATE AT TIME OF PROCEDURE. UNABLE TO PLACE, LACK OF PRIMARY STABILITY AT SITE #27. IMPLANT REMOVED, AREA BONE GRAFTED. ADDITIONAL APPOINTMENTS / IMPLANT RE-PLACEMENT: NOT INDICATED. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Information
MAUDE report 11287948 ↗InjuryNov 19, 2020Adverse 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 Information
MAUDE report 10867628 ↗InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT PATIENT DEVELOPED SWELLING ON THE PALATE. EDEMA NOT RESOLVING WITH ANTIBIOTICS. THE TSVH16 IMPLANT AT TOOTH SITE # 5 WAS REMOVED DUE TO INFECTION AND SITE GRAFTED.
Patient problems: Edema; Unspecified Infection
MAUDE report 10479905 ↗InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT (TSVH16) WAS REMOVED DUE TO PERIIMPLANTITIS. A FISTULA AND BONE LOSS WAS NOTED. TOOTH LOCATION 10.
Patient problems: Fistula; No Code Available; Unspecified Infection
MAUDE report 10232966 ↗InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S IMPLANT IN POSITION #6 DEVELOPED PERI-IMPLANTITIS DUE TO THE INFECTION IN THE ADJACENT TOOTH #7. THE SURGERY WAS NOT COMPLETED USING ANOTHER DEVICE. THERE WAS NO INJURY AS A RESULT OF THE PROCEDURE. IMPLANT WAS REMOVED AND BONE GRAFTING WAS PLACED.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9924538 ↗
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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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