Tapered Screw-Vent® TSVMH10Recalls & 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
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00889024344099), received between Apr 1, 2020 and Jun 3, 2026 — classified as 15 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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 Problem9
- Fracture6
- Mechanical Problem2
- Component Missing1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Unspecified Infection6
- Osteolysis4
- Inflammation2
- Abscess1
- Erosion1
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO BONE LOSS. PATIENT WILL RETURN TO REPLACE IMPLANT.
Patient problems: Osteolysis
MAUDE report 25383034 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. THE PATIENT CAME IN FOR UNCOVERY. UPON REVIEW OF THE PA, THERE WAS BONE LOSS
Patient problems: Osteolysis
MAUDE report 25031291 ↗InjuryApr 2, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765892 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO A LACK OF STABILITY ASSOCIATED WITH INFECTION. EXAMINATION AND X-RAY IMAGING CONFIRMED THAT THE IMPLANT SITE WAS INFECTED. THIS WAS NOTED DURING AN IMPLANT UNCOVERING PROCEDURE. THE IMPLANT REMOVAL TOOL WAS BROKEN DURING REMOVAL. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24746363 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. CONTINUES TO HAVE ISSUES WITH IMPLANTS ON THIS SITE. TOOTH NUMBER 28. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 24257289 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 29 WAS REMOVED DUE TO INFECTION. WILL PLACE A NEW IMPLANT AT A LATER DATE.
Patient problems: Unspecified Infection
MAUDE report 24225829 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES #7 AND #10 WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22529484 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES #7 AND #10 WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22529442 ↗InjuryDec 5, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 20857024 ↗InjuryOct 28, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547269 ↗MalfunctionJul 16, 2024Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19756324 ↗InjuryJun 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508827 ↗InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI-IMPLANTITIS WITH INFLAMMATION AT TOOTH SITE 23.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 15901360 ↗InjuryAug 19, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE SITE.
Patient problems: Insufficient Information
MAUDE report 15257536 ↗MalfunctionApr 21, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE, THE IMPLANT BODY COULD NOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167273 ↗MalfunctionApr 13, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DOCTOR BELIEVES THE IMPLANT IN SITE #29 HAS AN ISSUE WITH THE INTERNAL THREADS. IMPLANT CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14106661 ↗InjuryMar 18, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO THE LIP OF THE IMPLANT BECOMING FRACTURED. TOOTH #20.
Patient problems: Failure of Implant
MAUDE report 13803662 ↗MalfunctionJul 14, 2021Component 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 12165287 ↗InjuryApr 1, 2020Adverse 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 LOST INTEGRATION AND WAS REMOVED. PER INDICATED: LOSS OF INTEGRATION, PLACEMENT AND REMOVAL DATE (B)(6) 2020. ADDITIONAL APPOINTMENT REQUIRED: YES, NO DETAILS FOR NEXT APPOINTMENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NOTHING REPORTED CUSTOMER REPORTED LOSS OF INTEGRATION ON THE PER FORM. DUE TO THE TIME THE IMPLANT WAS IN THE PATIENTS¿ MOUTH, IT IS DETERMINED THAT THE COMPLAINT CATEGORY REFLECTED AS UNABLE TO PLACE IN OSTEOTOMY.
Patient problems: No Information
MAUDE report 9911047 ↗
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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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