Tapered Screw-Vent® TSVMWH10Recalls & 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 dental implant has 24 adverse event reports, with 12 injuries and no deaths. Reports mostly describe implants being removed because of infection, bone loss, or failure to heal, as well as the mount getting stuck on the implant and parts separating. 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
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024344143), received between Dec 20, 2019 and Apr 1, 2026 — classified as 12 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (10 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 Problem11
- Separation Failure10
- Fracture2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Unspecified Infection7
- Osteolysis5
- Inflammation2
- Abscess1
- Insufficient Information1
- No Information1
- Pain1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. THE PATIENT HAD SWELLING AND PAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, SWELLING AND PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24756064 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24277318 ↗MalfunctionNov 14, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560073 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT DID NOT HEAL AND BONE DID NOT FILL IN AROUND THE IMPLANT. THERE WAS ACTIVE INFECTION PRIOR TO PLACEMENT THAT MAY HAVE BEEN THE CAUSING FACTOR. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. TOOTH LOCATION IS UNKNOWN.
Patient problems: Inflammation; Osteolysis
MAUDE report 23523327 ↗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 21633561 ↗MalfunctionMar 7, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT THE MOUNT COULD NOT BE REMOVED AFTER IMPLANTATION AT TOOTH LOCATION #4. THE IMPLANT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548567 ↗MalfunctionJan 9, 2025Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113110 ↗MalfunctionJul 16, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE MOUNT WAS NOT REMOVABLE. THE DOCTOR ROUTINELY LOOSENS THE SCREWS ON THE MOUNT, BUT ONCE IT WAS INSERTED, THE MOUNT WOULD NOT COME OFF. HE DEALT WITH THE PROBLEM BY USING A SUBSTITUTE PRODUCT FROM THE HOSPITAL'S STOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19752035 ↗MalfunctionJun 21, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS PLACED AND THEN THE PIN FRACTURED, IT WAS REMOVED AT THE SAME TIME AND SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19584405 ↗MalfunctionJun 18, 2024Separation Problem; Separation Problem
IT WAS REPORTED THAT MOUNT DID NOT COME OFF. AFTER THE IMPLANT WAS INSERTED, THE MOUNT AXIS COULD NOT BE REMOVED AND IT WAS REMOVED AND RE-IMPLANTED WITH THE SAME SIZE FROM STOCK. HE TRIED TO REMOVE IT AFTER THE SURGERY BUT IT WOULD NOT COME OFF. PROCEDURE COMPLETED WITH ANOTHER SAME SIZE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563543 ↗MalfunctionNov 22, 2023Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18197071 ↗InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Osteolysis
MAUDE report 17076188 ↗InjuryMay 12, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16920242 ↗InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15770914 ↗InjuryAug 9, 2022Adverse 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 INFECTION AT THE IMPLANT SITE.
Patient problems: Abscess; Unspecified Infection
MAUDE report 15190843 ↗InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE # 19 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14719980 ↗MalfunctionApr 21, 2022Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14175181 ↗MalfunctionApr 19, 2022Separation Failure; Separation Failure
IT WAS REPORTED THAT DR. INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141415 ↗MalfunctionApr 19, 2022Separation Failure; Separation Failure
IT WAS REPORTED THAT DR. INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141307 ↗MalfunctionDec 1, 2021Separation Failure; Separation Failure
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 12913450 ↗MalfunctionNov 12, 2021Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT MOUNT WAS UNABLE TO BE REMOVED FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH #19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804232 ↗InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE TSVMWH10 IMPLANT IN TOOTH SITE # 30 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Unspecified Infection
MAUDE report 10874888 ↗InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY. TOOTH LOCATION 29.
Patient problems: No Information
MAUDE report 9591640 ↗InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT (TSVMH10) WAS REMOVED DUE TO INFECTION. SITE WAS BONE GRAFTED.
Patient problems: Unspecified Infection
MAUDE report 9503751 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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