Tapered Screw-Vent® TSVTB13Recalls & 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 is a dental implant screw placed in the jawbone to support a replacement tooth. Of its 276 reports, 264 are injury reports and 12 are malfunction reports, with no deaths. They mostly describe infections and bone loss around the implant, often leading to its removal, and some describe fractures. 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
- 271
- Deaths reported
- 0
- Injuries reported
- 259
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 00889024019942), received between Sep 26, 2019 and Sep 17, 2026 — classified as 259 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 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 Problem227
- Fracture31
- Mechanical Problem6
- Separation Failure3
- Component Missing2
- Loss of Osseointegration2
- Insufficient Device Problem Information1
- Packaging Problem1
Patient problems
- Unspecified Infection150
- Osteolysis86
- Pain68
- Inflammation51
- No Clinical Signs, Symptoms or Conditions51
- Abscess21
- No Information21
- Swelling/ Edema15
Recent adverse event reports
The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that two implants were removed due to an infection and a bone loss. Tooth sites 23 and 26.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50798908 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that two implants were removed due to an infection and a bone loss. Tooth sites 23 and 26.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50798827 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 25448936 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HURTING AROUND THE AREA OF THE IMPLANT AT TOOTH SITE # 5 AND THERE WAS A DEEP POCKET WITH DRAINAGE. THE PATIENT WASN'T TOLERATING ANTIBIOTICS AND WANTED TO GO FORWARD WITH REMOVAL. THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25171002 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO INFECTION. THE IMPLANT FAILED APPROXIMATELY THREE YEARS AFTER THE PLACEMENT DUE TO INFECTION. THE IMPLANT SUPPORTED MN DENTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24715821 ↗InjuryMar 18, 2026Fracture
IT WAS REPORTED THAT A PORTION OF THE IMPLANT AT TOOTH SITE #12 WAS FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630071 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24588779 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT SITE 10 WAS REMOVED DUE TO PERI IMPLANTITIS. IMPLANT MOBILE AND LOST INTEGRATION. SURGERY TO REMOVE IMPLANT AND REGRAFT. WILL RETURN TO HAVE NOTED PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24532817 ↗InjuryFeb 27, 2026Fracture
IT WAS REPORTED THAT THE PATIENT CAME TO THE OFFICE WITH THE IMPLANT FROM TOOTH SITE #29 IN HAND. THE TOP OF THE IMPLANT HAD FRACTURED SO WE REMOVED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470442 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO INFECTION. IMPLANT EXPOSED ON THE LINGUAL SITE OF PLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 24442905 ↗InjuryFeb 20, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED AS IT WAS FRACTURED & ALSO HAD AN INFECTION. COLLAR FRACTURE / INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24402144 ↗InjuryFeb 16, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345642 ↗MalfunctionFeb 13, 2026Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330950 ↗InjuryFeb 12, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24327168 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24081638 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24080864 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 32 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 24011132 ↗InjuryDec 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 #23 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23783423 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DUE TO CRESTAL BONE LOSS, THE IMPLANTS AT TOOTH SITES #5 AND #6 HAD TO BE REMOVED AND REPLACED.
Patient problems: Osteolysis
MAUDE report 23749466 ↗InjuryDec 8, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743738 ↗InjuryDec 5, 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 #24 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION AND PUS.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23733372 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN, EDEMA AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 23702431 ↗InjuryDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 HAD A FRACTURED PLATFORM AND HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23695012 ↗InjuryNov 17, 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: Osteolysis; Pain
MAUDE report 23568420 ↗InjuryOct 27, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23393644 ↗
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- 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.
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