Tapered Screw-Vent® TSVWH11Recalls & 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 implant is an endosseous dental implant. Reports mainly describe implant infections, inflammation, bone loss and implant removal, sometimes with fractured or loose components. It has 91 adverse event reports, 88 injuries, and no deaths. No recalls name this device. Reports dropped from 14 to 7 in the most recent 12 months.
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
- 92
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00889024020108), received between Mar 20, 2020 and Jul 31, 2026 — classified as 89 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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 Problem74
- Fracture17
- Appropriate Device Problem Term/Code Not Available1
- Loss of Osseointegration1
- Mechanical Problem1
- Patient-Device Incompatibility1
- Separation Failure1
- Unintended Movement1
Patient problems
- Unspecified Infection59
- Osteolysis52
- Inflammation21
- Pain16
- No Clinical Signs, Symptoms or Conditions13
- Swelling/ Edema11
- No Code Available8
- No Information6
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant was removed due to infection. Tooth site 36. Site presented periapical inflammation.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50096211 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO BONE LOSS & INFECTION. PT REPORTED THE GUM TISSUE IN THE IMPLANT AREA WAS TENDER AND WHEN SHE PUSHED ON THE IMPLANT THERE WAS PUS COMING OUT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24686931 ↗InjuryFeb 25, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort
MAUDE report 24441171 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT A FOLLOW UP APPOINTMENT, INFECTION WAS FOUND AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED AND THE SITE WAS DEBRIDED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24278967 ↗InjuryJan 8, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO A BROKEN PLATFORM. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO PLACE BONE IN THE TOOTH SITE AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24007552 ↗InjuryDec 17, 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
MAUDE report 23828337 ↗InjuryDec 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A CHECKUP, DOCTOR FOUND OUT IMPLANT AT TOOTH SITE # 26 WAS MOBILE AND WHILE UNSCREWING HE SAW THE COLLAR OF THE IMPLANT WAS FRACTURED. IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702780 ↗InjuryNov 16, 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 CRESTAL BONE LOSS AND PAIN ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23565701 ↗InjuryOct 29, 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 #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23417139 ↗InjuryOct 16, 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, #6, #11 & #14 WERE REMOVED DUE TO BONE LOSS. PATIENT HAD ALL ON 4. PATIENT C/O PAIN UPPER R AND L AND FEELS LIKE PROSTHESIS IS LOOSE. AFTER EXAM FOUND POCKETING AROUND 4 IMPLANTS. ALL ARE MOBILE AND REMOVED. PLACED BONE GRAFT FOR POSSIBLE FUTURE IMPLANTS PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO, PLACED BONE GRAFTING FOR POSSIBLE FUTURE IMPLANTS. NEED TO DISCUSS TREATMENT PLAN WITH DDS AND RELEVANT PATIENT HISTORY. WAS THERE A DELAY DURING THE PROCEDURE: NO ADDITIONAL APPOINTMENT REQUIRED: NO SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23319372 ↗InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 16 & 26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN, INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22951578 ↗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 # 30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22880338 ↗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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WERE ABSCESS, AND BONE LOSS.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22880299 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #17 & UNKNOWN FAILED, DUE TO PERI-IMPLANTITIS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22294401 ↗InjuryJun 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22285060 ↗InjuryJun 17, 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. PATIENT HAS HISTORY OF LYMPHOMA WITH RADIATION AND CHEMO. PATIENT/DR DECIDED IT WAS BEST TO REMOVE IMPLANT AND NOT REPLACE IT DUE TO MEDICAL HISTORY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22236701 ↗InjuryFeb 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21470101 ↗InjuryDec 30, 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; Unspecified Infection
MAUDE report 21034547 ↗InjuryNov 11, 2024Adverse 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; Swelling/ Edema; Unspecified Infection
MAUDE report 20650310 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED WITH PAIN AREA OF IMPLANT. BONE LOSS NOTED ON PANOREX. IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 20636458 ↗InjuryNov 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO THE IMPLANT BEING FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20599837 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTIST FELT AREA WAS INFECTED, PLACED ON ANTIBIOTICS. TOOTH #4 (UNIVERSAL).
Patient problems: Unspecified Infection
MAUDE report 20597995 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AT TIME OF HEALING COLLAR PLACEMENT IMPLANT WAS MOBILE WITH INFLAMMATION TISSUE AROUND IT. HEALING COLLAR PLACED (B)(6) 2023 AND TEEHA455 PLACED (B)(6) 2023. ON (B)(6) 2024, DENTIST FELT AREA WAS INFECTED, PLACED ON ANTIBIOTICS. THIS EVENT IS GOING TO BE REPORTED UNDER (B)(4). PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: NONE. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20555669 ↗InjuryOct 24, 2024Fracture; Fracture
IT WAS REPORTED THAT PATIENT CAME FOR EVALUATION IMPLANT #19, CROWN FELL OFF AND CLINICALLY THE ABUTMENT SCREW IS VISIBLE THROUGH TISSUE. X-RAY SHOWS #19 IMPLANT IS FRACTURED AND HOPELESS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation
MAUDE report 20529507 ↗MalfunctionAug 12, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 WAS REMOVED BECAUSE THEY COULD NOT REMOVE THE MOUNT. A DIFFERENT IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961774 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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