Tapered Screw-Vent® TSVMWH11Recalls & 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
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024344150), received between Dec 20, 2019 and Jan 23, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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 Problem7
- Fracture1
Patient problems
- Unspecified Infection6
- Osteolysis4
- Inflammation2
- Abscess1
- Erosion1
- Failure of Implant1
- Sensitivity of Teeth1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO MOBILITY ASSOCIATED WITH PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 24164813 ↗InjuryNov 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 #8 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.
Patient problems: Inflammation; Osteolysis
MAUDE report 23523435 ↗InjuryApr 3, 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 #5 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21770249 ↗InjuryAug 18, 2022Fracture; Fracture
NO EVENT WAS REPORTED BY THE CUSTOMER HOWEVER THE IMPLANT WAS RECEIVED FRACTURED AT THE IMPLANTS HEAD.
Patient problems: Failure of Implant
MAUDE report 15253006 ↗InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT A 1 MONTH TISSUE CHECK, THE PATIENT HAS PERI-IMPLANTITIS, SENSITIVITY AND INFLAMMED TISSUES AROUND THE IMPLANT AT TOOTH LOCATION #4.
Patient problems: Inflammation; Osteolysis; Sensitivity of Teeth; Unspecified Infection
MAUDE report 14982172 ↗InjuryOct 12, 2021Adverse 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 12619088 ↗InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 6 WAS REMOVED DUE TO INFECTION. PATIENT TO RETURN FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 10236687 ↗InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT (TSVMWH11) WAS REMOVED DUE TO INFECTION. SITE WAS BONE GRAFTED.
Patient problems: Unspecified Infection
MAUDE report 9503664 ↗
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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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