Tapered Screw-Vent® TSV6H10Recalls & 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 TSV6H10 is a root-form endosseous dental implant used to anchor a tooth replacement. The 69 adverse event reports mostly describe implants becoming loose or falling out, often with pain, swelling, and infection around the implant site, and some implants breaking; 68 reports involved injuries and no deaths were reported. No recalls name this device. Reports have slowed in the past 12 months, with 6 compared to 15 in the previous 12 months.
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
- 69
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00889024019454), received between Nov 21, 2019 and Sep 17, 2026 — classified as 68 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (9 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 Problem60
- Fracture9
- Unsealed Device Packaging1
Patient problems
- Osteolysis42
- Unspecified Infection42
- Pain15
- Inflammation12
- No Clinical Signs, Symptoms or Conditions10
- Swelling/ Edema5
- Abscess3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Fracture
It was reported that an implant was removed due to implant fracture, another implant was placed, and the bone was grafted. Tooth site 19.Bone density type: III
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798500 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED, CAME INTO CLINIC SAYING IMPLANT WAS LOOSE, MADE APPT TO REMOVE AND IT EVULSED AT HOME, PATIENT CAME IN FOR GRAFTING ON (B)(6) 2026.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25243542 ↗InjuryMay 5, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT PLATFORM AT TOOTH SITE #30 WAS FRACTURED. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085733 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS ANESTHETIZED AND REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS NOTED TO HAVE BEEN PLACED IN 2017. IN (B(6) 2026 THE PATIENT BEGAN EXPERIENCING PAIN AT THE SITE AND MOBILITY OF THE IMPLANT AND CROWN. THE CUSTOMER OPTED NOT TO IMMEDIATELY REPLACE THE IMPLANT, BUT AN ADDITIONAL APPOINTMENT IS ANTICIPATED TO REPLACE THE IMPLANT IN THE FUTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24640968 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED INTO EDENTULOUS SITE #19 (B)(6) 2022, REMOVED (B)(6) 2025 DUE TO PERIIMPLANTITIS. SURGERY TO REMOVE IMPLANT WAS DONE, SITE WAS GRAFTED WITH BONE. IMPLANT REPLACEMENT SIX MONTHS FROM REMOVAL DATE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24232721 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PRESENTED, NOTING THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE HAD FALLEN OUT ON IT'S OWN. INFECTION WAS NOTED. ADDITIONAL APPOINTMENTS WERE ANTICIPATED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 24203089 ↗InjuryOct 30, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23430368 ↗InjuryOct 30, 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23427192 ↗InjuryJul 28, 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. CUSTOMER REPORTED X-RAY WAS OBTAINED AND WAS NOTED THAT PATIENT HAD BONE LOSS AROUND IMPLANT. IMPLANT WAS REMOVED WITH TORQUE WRENCH AND BONE GRAFT PLACED FOR REPLACEMENT IN FUTURE, TOOTH 19.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22628975 ↗InjuryJul 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22586079 ↗InjuryJul 23, 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 #2 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22574359 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22353072 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DDS SAW THE PATIENT AND NOTED SIGNIFICANT BONE LOSS AT CREST OF THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22327355 ↗InjuryJun 17, 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 #30 WAS REMOVED DUE TO BONE LOSS. CLINICALLY FOUND A BUCCAL FISTULA WITH PROBING DEPTHS AND BLEEDING.
Patient problems: Osteolysis
MAUDE report 22236589 ↗InjuryMay 16, 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 INFECTION ON TOOTH 3.
Patient problems: Unspecified Infection
MAUDE report 22039428 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DID NOT COME IN FOR THE REGULAR CHECK-UP AFTER IMPLANT PLACEMENT AT TOOTH SITE #3. THE PATIENT WAITED 14 WEEKS TO COME IN AND THERE WAS AN INFECTION THAT CAUSED SINUS PERFORATION. THE IMPLANT WAS REMOVED, SINUS CLOSURE WAS PERFORMED AND ANTIBIOTICS WERE PRESCRIBED.
Patient problems: Sinus Perforation; Unspecified Infection
MAUDE report 22006252 ↗InjuryMay 12, 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 22006065 ↗InjuryApr 30, 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 PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21936499 ↗InjuryMar 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21565875 ↗InjuryJan 31, 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 21282118 ↗InjuryNov 6, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622233 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE #3 CAME OUT WHILE EATING DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 20493584 ↗InjurySep 17, 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
MAUDE report 20238949 ↗InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19917810 ↗InjuryJun 28, 2024Adverse 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; Pain; Unspecified Infection
MAUDE report 19634501 ↗
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