Tapered Screw-Vent® TSVMWB11Recalls & 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 is a root-form dental implant placed in the jaw. The FDA records hold 97 reports, with no deaths and 86 injuries; recent reports describe infection and bone loss around the implant, often leading to its removal, and a mount that broke during placement. 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
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00889024019782), received between Oct 31, 2019 and Sep 7, 2026 — classified as 88 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem73
- Fracture20
- Component Missing3
- Mechanical Problem3
- Connection Problem1
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- Unspecified Infection53
- Osteolysis36
- Inflammation26
- Pain21
- No Clinical Signs, Symptoms or Conditions16
- Abscess6
- No Information6
- Swelling/ Edema4
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50647336 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
The implant at tooth #19 failed due to infection and associated tenderness in the area.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50297740 ↗InjuryJul 27, 2026Fracture
It was reported that the patient showed bone loss around implant. The crown was removed and the implant was found to be broken, so it was removed. Patient suffered from inflammation. Procedure was not completed.
Patient problems: Inflammation; Osteolysis
MAUDE report 50032321 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 24 AND 25 WERE REMOVED DURING WOUND EXAMINATION AFTER SURGERY DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. DOCTOR ALSO INDICATED PROGRESSIVE BONE LOSS DUE TO PERI-IMPLANTITIS SINCE 2022. DOCTOR PRESCRIBED TREATMENT WITH PERIOFLOW AND LIGOSAN GEL, THERE WAS PURULENT DISCHARGE ON (B)(6) 2024. LIGOSAN WAS USED AGAIN UNTIL EXTRACTION ON (B)(6) 2024.
Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 25168257 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25055993 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24461888 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. THE TOOTH SITE LOCATION IS UNKNOWN.
Patient problems: Osteolysis
MAUDE report 24460977 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24393325 ↗MalfunctionFeb 17, 2026Fracture
DOCTOR REPORTED THAT THE IMPLANT COULD NO LONGER BE UNSCREWED FROM THE LOWER JAW AFTER IT HAD BEEN SCREWED IN WITH ONLY HALF OF THE THREAD, THE PROCEDURE WAS DELAYED TO REMOVE THE IMPLANT. ANOTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. UPON REVIEW/INSPECTION OF RETURNED PRODUCT. THE IMPLANT/MOUNT WERE RETURNED DISENGAGED. HOWEVER, THE BUNDLED MOUNT WAS FRACTURED AT THE HEX. AFTER FOLLOW UP WITH THE DOCTOR, HE CONFIRMED THAT THE MOUNT FRACTURED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362519 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND #14 WERE REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. ADDITIONAL APPOINTMENTS WERE ANTICIPATED TO REPLACE THE IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24262563 ↗InjuryJan 21, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 (FDI) WAS BOTHERING THE PATIENT. THE DENTIST REMOVED THE CROWN AND CLEANED AROUND THE ABUTMENT AND WHEN DOING SO, NOTICED THAT THE IMPLANT WAS FRACTURED. THE IMPLANT WAS REMOVED.
Patient problems: Discomfort
MAUDE report 24131845 ↗InjuryOct 24, 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. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23382047 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #19 AND #30 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23359492 ↗InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS BEING SEEN BY A PROSTHODONTIST TO HAVE THE HYBRID DENTURE TORQUED TO PLACE WHEN IT WAS NOTED THAT THE PATIENT HAD PAIN AROUND THE IMPLANT AT TOOTH SITE #29 WHEN TORQUEING THE ABUTMENT SCREW. THE IMPLANT WAS PLACED AND TORQUED TO 50NCM. IT WAS IMMEDIATELY LOADED AS PART OF A HYBRID LOWER DENTURE. THE PATIENT WAS ASSESSED BY CLINICIAN AND IT APPEARED ON RADIOGRAPH THAT THE IMPLANT HAD "UNZIPPED". THE HYBRID DENTURE WAS REMOVED AND THE IMPLANT AT THIS SITE HAD SLIGHT MOBILITY. AFTER GIVING LOCAL ANESTHETIC, THE IMPLANT WAS REMOVED BY UNSCREWING IT BY HAND. ALTHOUGH IMPLANT THREADS COULD BE FELT ALL AROUND OSTEOTOMY, THE IMPLANT HAD FAILED TO INTEGRATE. SOME EPITHELIUM WAS REMOVED FROM THE SOCKET AND IS BEING ALLOWED TO HEAL ON IT'S OWN. THERE WAS NO SOFT TISSUE AROUND THE IMPLANT AT REMOVAL AND NONE IN THE SOCKET.
Patient problems: Pain
MAUDE report 22976482 ↗InjuryAug 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED AS IT WAS FRACTURED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22833944 ↗InjuryJun 25, 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 PERI-IMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WAS REMOVED, TOOTH 5. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22332025 ↗InjuryJun 24, 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 PERIIMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22324719 ↗InjuryMay 8, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 37 WAS REMOVED DUE TO INFECTION AND IMPLANT FRACTURE. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. DOCTOR PERFORMED CLEANING AND AUGMENTATION FOR A LATER IMPLANTATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 21986392 ↗InjuryApr 29, 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 21926958 ↗InjuryApr 15, 2025Fracture; Fracture
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE. TOOTH SITE: 19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21843810 ↗InjuryFeb 5, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 21313420 ↗InjuryFeb 4, 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
MAUDE report 21307057 ↗MalfunctionDec 10, 2024Component Missing; Component Missing
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20889798 ↗InjuryNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20813648 ↗InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ANTIBIOTICS WERE PRESCRIBED DUE TO INFECTION. BONE LOSS IS ALSO REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20728831 ↗
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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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