Tapered Screw-Vent® TSVTB8Recalls & 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 an implant placed into bone. Many of the 135 reports describe infection and bone loss around the implant, often leading to its removal, and some mention pain and swelling. There are no deaths and 127 injuries, and reports fell from 36 in the previous 12 months to 16 in the latest 12 months. 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
- 135
- Deaths reported
- 0
- Injuries reported
- 127
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00889024019966), received between Mar 25, 2020 and May 26, 2026 — classified as 127 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 Problem115
- Fracture8
- Separation Failure5
- Patient-Device Incompatibility4
- Detachment of Device or Device Component1
- Failure to Osseointegrate1
- Loss of Osseointegration1
- Mechanical Problem1
Patient problems
- Unspecified Infection76
- Osteolysis67
- Pain37
- Inflammation22
- No Clinical Signs, Symptoms or Conditions22
- Abscess9
- Erosion4
- Hypersensitivity/Allergic reaction4
Recent adverse event reports
The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT DEVELOPED PURULENCE AND BECAME LOOSE. SITE HAD TO BE BONE GRAFTED AND MEMBRANE PLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA, AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25277273 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO INFECTION. PATIENT RETURNED WITH INFECTION AND IMPLANT NEEDED TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 25247671 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO REMOVABLE PARTIAL DENTURE (RPD) PRESSURE AND PERI-IMPLANTITIS, THE IMPLANT AT TOOTH SITE #29 REQUIRED EARLY REMOVAL.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25209529 ↗MalfunctionApr 11, 2026Fracture
IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT, IT WAS IDENTIFIED THAT THE IMPLANT HAS A SMALL FISURE AT THE HEX. TOOTH LOCATION 36. OTHER IMPLANT PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851269 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 HAD SEVERE BONE LOSS. THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24594109 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24558456 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #5, #6 AND #7 HAD BECOME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24552304 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #5, #6 AND #7 HAD BECOME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24552232 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #5, #6 AND #7 HAD BECOME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24552072 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4, #5, #6 AND #7 HAD BECOME LOOSE AND WERE REMOVED DUE TO INFECTION. ANTIBIOTICS WERE SUPERSCRIPTED ON THE EVENT DATE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24551984 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24348513 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Sinus Perforation
MAUDE report 24330438 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 HAD SENSITIVITY, BECAME LOOSE AND FELL OUT AT HOME DUE TO PERI-IMPLANTITIS.
Patient problems: Hyperresponsive to stimuli; Osteolysis; Unspecified Infection
MAUDE report 24081949 ↗InjuryDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED AS IT WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862764 ↗InjuryDec 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS AND A BONE GRAFT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23856276 ↗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 #35 WAS REMOVED DUE TO PERI-IMPLANTITIS. DISCOVERED DURING IMPLANT UNCOVERING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23524498 ↗InjuryOct 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #25 & #14 FAILED DUE TO AN ALLERGIC REACTION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23400663 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND 13 WERE REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23097701 ↗InjurySep 18, 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 & INFECTION. IMPLANT BECOME LOOSE. ANTIBIOTIC SUPERSCRIPTED ON THE EVENT DATE SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23089560 ↗InjurySep 18, 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 & INFECTION. IMPLANT BECOME LOOSE. ANTIBIOTIC SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23089558 ↗InjurySep 18, 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 & INFECTION. IMPLANT BECOME LOOSE. ANTIBIOTIC SUPERSCRIPTED ON THE EVENT DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23089521 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED INFECTION AND BONE LOOS. THE PATIENT WAS PRESCRIBED ANTIBIOTIC (AMOXICILLIN) BEFORE THE IMPLANT WAS REMOVED. THIS COMPLAINT WAS CREATED TO CAPTURE THAT EVENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN. (B)(6) 2025 - SPOKE TO DR (B)(6), WHO STATED: 1. ANTIBIOTICS WERE PRESCRIBED ON (B)(6) 2025. 2. PAIN MEDS WERE PRESCRIBED ON (B)(6) 2025.
Patient problems: Pain; Unspecified Infection
MAUDE report 23087852 ↗InjuryAug 13, 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 PERI-IMPLANTITIS. TOOTH SITE #35. SYMPTOM REPORTED ON THE PATIENT WAS INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22797914 ↗InjuryAug 5, 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 22713383 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXTRACTION OF THE TOOTH #18 AND THE IMPLANT AT TOOTH SITE #19 WAS NOTICED TO HAVE SIGNIFICANT BONE LOSS SURROUNDING THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22476126 ↗
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