Tapered Screw-Vent® TSVTWB13Recalls & 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 has 166 reports, with no deaths and 155 injuries. Many reports describe infection and bone loss around the implant, which led to removal, and some describe fractures and pain. No recalls name this device, and reports fell from 26 in the prior 12 months to 11 in the latest 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
- 164
- Deaths reported
- 0
- Injuries reported
- 153
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00889024020016), received between Aug 20, 2019 and Sep 14, 2026 — classified as 153 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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 Problem135
- Fracture17
- Mechanical Problem5
- Patient-Device Incompatibility2
- Unsealed Device Packaging2
- Component Missing1
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- Unspecified Infection82
- Osteolysis57
- Pain44
- No Clinical Signs, Symptoms or Conditions31
- Inflammation28
- No Information15
- Abscess9
- Swelling/ Edema6
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant was removed due to an infection at tooth 19. The patient reported experiencing excessive pain.
Patient problems: Pain; Unspecified Infection
MAUDE report 50750810 ↗InjuryAug 18, 2026Fracture
It was reported implant fracture and the implant was removed. Tooth Location 19.Bone graft was performed, guided surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301219 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO INFECTION. X-RAY EXAMINATION REVEALED FUNNEL-SHAPED BONE DEFECTS 3 MM DEEP AROUND BOTH IMPLANTS. THE PATIENT WAS EXPERIENCING GENERAL SYMPTOMS, INCLUDING FEVER. PROCEDURE WAS COMPLETED PLACING TWO TSX54B13 IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25171846 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO INFECTION. X-RAY EXAMINATION REVEALED FUNNEL-SHAPED BONE DEFECTS 3 MM DEEP AROUND BOTH IMPLANTS. THE PATIENT WAS EXPERIENCING GENERAL SYMPTOMS, INCLUDING FEVER. PROCEDURE WAS COMPLETED PLACING TWO TSX54B13 IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25171800 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO INFECTION. THE DOCTOR ALSO INDICATED FISTULA FORMATION PROBING DEPTH OF MAXIMUM 3 MM WAS PERFORMED. CROWN WAS REMOVED, CLEANED AND DISINFECTED, LIGOSAN WAS APPLIED AND CROWN WAS REFITTED. DOCTOR ALSO REPORTED PURULENT DISCHARGE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25171672 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 DID NOT INTEGRATE AND WAS REMOVED DUE TO BONE LOSS. THE SITE WAS GRAFTED AND AN ADDITIONAL APPOINTMENT IS ANTICIPATED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis
MAUDE report 24652031 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 24272635 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH PAIN. IT WAS NOTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED APPROXIMATELY THREE MONTHS FROM THE DATE OF THE IMPLANT REMOVAL FOR A GRAFT CHECK AND OR AN IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23928269 ↗InjuryDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED AS IT WAS FRACTURED. THE IMPLANT WAS REPLACED AND AN ADDITIONAL PROCEDURE WAS ANTICIPATED IN THREE TO FOUR MONTHS TO CONFIRM IMPLANT STABILITY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 23782776 ↗InjuryOct 31, 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 23441687 ↗InjuryOct 23, 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 LOOSENING. IMPLANT HAD TO BE REMOVED. TOOTH NUMBER 29. SYMPTOMS / PATIENT IMPACT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23376272 ↗InjuryOct 23, 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; Unspecified Infection
MAUDE report 23376072 ↗InjuryJul 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #26 FRACTURED AT THE PLATFORM. IMPLANT REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420282 ↗InjuryJun 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 #4 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 22293765 ↗InjuryJun 18, 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 HAD LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22285255 ↗InjuryJun 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 #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, DISCOMFORT, SWELLING AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22198473 ↗InjuryJun 5, 2025Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWO (2) MONTHS AGO, THE PATIENT WAS EATING AND HEARD A "SNAP" AND THE CROWN BECAME MOBILE. EVALUATION BY THE GENERAL DENTIST DETERMINED THAT A FRACTURE NEAR THE COLLAR OF THE IMPLANT AT TOOTH LOCATION #30 WAS NOTED. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150119 ↗InjuryApr 24, 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 BONE LOSS. TOOTH SITE # 25.
Patient problems: Osteolysis
MAUDE report 21898021 ↗InjuryApr 24, 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 BONE LOSS. TOOTH SITE # 25.
Patient problems: Osteolysis
MAUDE report 21897961 ↗InjuryApr 21, 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 21876889 ↗InjuryApr 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 #13 WAS REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21855637 ↗MalfunctionApr 11, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS MISSING THE CENTER SCREW. NO CENTER SCREW IN PACKED IMPLANT, SO IMPLANT FELL OUT WHEN DR PLACED CARRIER. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. THERE WAS A DELAY DURING THE PROCEDURE, HAD TO GET ADDITIONAL RDA TO OPEN CABINET TO RETRIEVE ANOTHER AND OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21829801 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND DISCOMFORT AROUND THE IMPLANT AT TOOTH LOCATION #18. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Discomfort; Osteolysis; Pain
MAUDE report 21712319 ↗MalfunctionMar 6, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536479 ↗InjuryMar 4, 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 #20 WAS REMOVED DUE TO INFECTION. PT CAME IN WITH INFECTION #20 IMPLANT. BONE LOSS ON FACIAL. IMPLANT REMOVED & GRAFTED. PT TO FOLLOW UP 3 - 4 MONTHS FOR REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 21514030 ↗
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