Tapered Screw-Vent® TSVH11Recalls & 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 dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Many of the 112 reports describe bone loss and infection around the implant, and some describe the implant fracturing. The reports include 101 injuries and no deaths. 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
- 114
- Deaths reported
- 0
- Injuries reported
- 103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00889024019577), received between Jul 3, 2020 and Sep 16, 2026 — classified as 103 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (27 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 Problem72
- Fracture27
- Component Missing4
- Mechanical Problem2
- Separation Failure2
- Unsealed Device Packaging2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
Patient problems
- Osteolysis55
- Unspecified Infection49
- No Clinical Signs, Symptoms or Conditions36
- Pain19
- Inflammation14
- No Information7
- Erosion4
- Abscess3
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Fracture
It was reported that two components fractured during clinical use. The abutment broke off, leaving the screw inside the implant, and the platform of the implant fractured. Tooth site 29.A new implant will be placed after healing.This report refers to fractured implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784581 ↗InjurySep 2, 2026Fracture
The doctor reports that the dental implant failed because it fractured at the head. Tooth site 36. Implant was removed. The doctor reports that the procedure was not concluded by placing another implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564830 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24830509 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23981659 ↗InjuryDec 30, 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 23922654 ↗InjuryDec 18, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840635 ↗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 23832138 ↗InjuryDec 13, 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: Inflammation; Osteolysis
MAUDE report 23797726 ↗MalfunctionDec 11, 2025Component Missing; Component Missing
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23781474 ↗InjuryNov 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578956 ↗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 #10 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT C/O SWELLING/PAIN. IMPLANT APPEARS SOLID. IMPLANT CLINICALLY WITHIN NORMAL LIMITS. DDS PRESCRIBED AMOXICILLIN. PATIENT STATES SHE WAS PRESSING ON GUM TISSUE BY THE IMPLANT AND SIGNIFICANT AMOUNT OF "PUS AND BLOOD" DRAINED FROM THE AREA. PATIENT STATES SHE HAS NEEDED PAIN MEDICATION. EXAM: PROBING DEPTHS 12MM. IMPLANT WAS REMOVED. ABSCESS AROUND IMPLANT. AREA WAS GRAFTED. NEW IMPLANT PLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23522957 ↗InjuryNov 7, 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 23503751 ↗InjuryNov 6, 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; Unspecified Infection
MAUDE report 23486756 ↗InjuryNov 4, 2025Adverse 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; Unspecified Infection
MAUDE report 23463643 ↗InjuryOct 31, 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 #4 WAS REMOVED DUE TO INFECTION. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 23441899 ↗InjuryOct 31, 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 LOST INTEGRATION DUE TO SEVERE BONE LOSS. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23437304 ↗InjuryOct 29, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412372 ↗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 #29 WAS REMOVED DUE TO BONE LOSS. THREE MONTH POST-OPERATIVE BONE SURROUNDING IMPLANT WAS NOTED. PATIENT TO RETURN TO REEVALUATE AND CHECK HEALING. BONE GRAFT PLACED AT TIME OF IMPLANT REMOVAL. REPLACEMENT IMPLANT WAS PLACED ON (B)(6) 2025.
Patient problems: Osteolysis
MAUDE report 23316541 ↗InjurySep 18, 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 BONE LOSS AND INFECTION. IMPLANT WAS REMOVED WITH RONGUER, SOCKET CURETTED, IRRIGATED WITH STERILE SALINE. BONE GRAFTED AND TISSUE GRAFT HARVESTED FROM PALATAL AREA AND PLACED ON THE FACIAL. TOOTH 11.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23088504 ↗MalfunctionJul 24, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586371 ↗MalfunctionJul 24, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586313 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #25 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22467002 ↗InjuryJul 9, 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 UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION, ABSCESS, AND EDEMA.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22462955 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED: EDEMA, INFLAMMATION, BRUXISM, SMOKER.
Patient problems: Bruxism; Osteolysis; Unspecified Infection
MAUDE report 22456506 ↗InjuryJul 7, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 22420893 ↗
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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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