Tapered Screw-Vent® TSV4H10Recalls & 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 root-form implant. Reports mostly describe implant failures from peri-implantitis, bone loss, infection, pain, and parts fracturing or separating. 91 reports name its identifier, with 77 injuries and no deaths. There are no recalls for 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
- 90
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00889024019300), received between Jan 10, 2020 and Sep 7, 2026 — classified as 76 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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 Problem61
- Fracture16
- Separation Failure7
- Component Missing3
- Detachment of Device or Device Component2
- Air/Gas in Device1
- Mechanical Problem1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection38
- Osteolysis36
- Pain25
- No Clinical Signs, Symptoms or Conditions24
- Inflammation10
- No Code Available6
- No Information6
- Swelling2
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50646995 ↗InjurySep 1, 2026Fracture
It was reported that the implant platform fractured, tooth site 16.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545008 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant was lost due to peri-implantitis and subsequently removed. The patient is expected to return to complete the procedure.Tooth site 16.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50096296 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 FAILED AND WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24690528 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT BEGAN EXPERIENCING MOBILITY AT THE IMPLANT SITE, PERI-IMPLANTITIS WAS NOTED. IMPLANT WAS SURGICALLY REMOVED AND SITE GRAFTED WITH BONE SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24233997 ↗InjuryDec 18, 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; Pain
MAUDE report 23842606 ↗InjuryDec 12, 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 #14 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23791959 ↗InjuryDec 8, 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; Pain
MAUDE report 23744233 ↗InjuryDec 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: Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 23715740 ↗InjurySep 10, 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 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23014780 ↗InjuryAug 19, 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22843827 ↗InjuryAug 15, 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 #7 BECAME INFECTED PRIOR TO ACHIEVING OSSEOINTEGRATION. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 22814653 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT A FOLLOW-UP APPOINTMENT, THE IMPLANT AT TOOTH LOCATION #47 (FDI) WAS FOUND LOOSE DUE TO PERI-IMPLANTITIS. THE OPERATION WAS PERFORMED WITH LOCAL INJECTION OF ALTICAINE, EPINEPHRINE 1.7 MI, 47 LOCAL ANESTHESIA, INCISION OF THE GINGIVA, FLAP LOOSENING, IMPLANT REMOVAL, REMOVAL SCRATCHING, DEBRIDEMENT, IRRIGATION AND SUTURING. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22498945 ↗InjuryJul 13, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO FRACTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22490806 ↗InjuryMay 27, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088245 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 34 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21958723 ↗InjuryApr 23, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 FRACTURED AND IT NEEDS TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21895404 ↗MalfunctionApr 15, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT THE CLINICIAN ATTEMPTED IMPLANT PLACEMENT #13, IMPLANT SEATED AT 50NCM, IMPLANT CARRIER WOULD NOT DISENGAGE, ATTEMPTED TO DISENGAGE AND IMPLANT CAME OUT, OSTEOTOMY DAMAGED. PROCEDURE COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation
MAUDE report 21844266 ↗InjuryApr 3, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761843 ↗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 #19 WAS REMOVED AS THE ANGLE OF THE IMPLANT WAS TO CLOSE TO THE COPING. IMPLANT WILL BE PLACED AGAIN AT A DIFFERENT ANGLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469232 ↗InjuryFeb 13, 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.
Patient problems: Osteolysis
MAUDE report 21374632 ↗InjuryFeb 13, 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. SEVERE DENTAL DECAY AND PERIODONTAL DISEASE WAS NOTED IN ALL OF THE PATIENT'S MAXILLARY TEETH, ENCROACHING UPON THE IMPLANT OF TOOTH SITE #4.
Patient problems: Unspecified Infection
MAUDE report 21374580 ↗InjuryDec 9, 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; Pain; Unspecified Infection
MAUDE report 20876340 ↗MalfunctionSep 27, 2024Component Missing; Component Missing
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR REALIZED THAT THE IMPLANT CONTAINER WAS EMPTY. PROCEDURE WAS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319706 ↗InjurySep 25, 2024Adverse 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 SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Pain
MAUDE report 20302181 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page