Tapered Screw-Vent® TSVTWB10Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie Tapered Screw-Vent dental implant. The 618 reports mostly describe infection, peri-implantitis and bone loss leading to implant removal, with some describing implants that fractured. There are 559 injuries and no deaths. 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
- 618
- Deaths reported
- 0
- Injuries reported
- 558
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 618 adverse event reports that list this exact device (DI 00889024019997), received between Aug 30, 2019 and Sep 29, 2026 — classified as 558 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Fracture” (96 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem476
- Fracture96
- Mechanical Problem23
- Separation Failure15
- Component Missing13
- Loss of Osseointegration6
- Device Damaged by Another Device1
- Electromagnetic Compatibility Problem1
Patient problems
- Unspecified Infection307
- Osteolysis248
- Pain148
- No Clinical Signs, Symptoms or Conditions142
- Inflammation97
- No Information32
- Abscess30
- Swelling/ Edema28
Recent adverse event reports
The 25 most recent of 618 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
It was reported that the implant carrier fractured abnormally at the connection, leaving a fragment lodged within the implant connection and the implant was removed. Tooth site 37.The implant was removed and replaced with a new implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929255 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implants were removed due to peri-implantitis at tooth site 15. The patient experienced an abscess accompanied by pain, edema, and significant inflammation.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50750718 ↗InjuryAug 18, 2026Fracture
It was reported that the implant fractured and lost integration. Patient will return for new implant placement. Tooth site 19.Noted Swelling and Pain.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50301329 ↗InjuryJul 31, 2026Fracture; Loss of Osseointegration
It was reported that the implant at tooth site 19 was mobile and was removed due to implant fracture. Loss of integration with bone loss was also reported. Other appointment is needed to replace the implant.
Patient problems: Osteolysis
MAUDE report 50096632 ↗InjuryJun 9, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 FRACTURED AND WAS REMOVED. TOP PART OF IMPLANT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448423 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PAIN. PATIENT COMPLAINED OF PAIN SINCE IMPLANT WAS PLACED IN SITE 30.
Patient problems: Pain
MAUDE report 25435795 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING EXTRACTION OF ANOTHER TOOTH, IT WAS NOTED THAT IMPLANT #3 HAD FAILED DUE TO INFECTION/PERI-IMPLANTITIS. BONE LOSS WAS ALSO NOTED. IMPLANT WAS REMOVED AT THAT TIME.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25435657 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Inflammation; Osteolysis
MAUDE report 25302782 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260252 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25260249 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260247 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260246 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260242 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260237 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260236 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25260228 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WERE SLOW ADVANCING BONE LOSS AND MOBILITY AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN
Patient problems: Osteolysis; Pain
MAUDE report 25218110 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS. THE GENERAL DENTIST NOTICED BONE LOSS AROUND THE IMPLANT DURING A REGULAR CHECK-UP EXAMINATION. THE PATIENT WAS REFERRED TO THE CUSTOMER'S OFFICE FOR FOLLOW-UP. THE IMPLANT WAS REMOVED AND A NEW BONE GRAFT WAS PLACED IN THE SITE IN ANTICIPATION FOR A REPLACEMENT IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24985051 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS INFECTION AND BONE LOSS PRESENT AROUND THE IMPLANT AT TOOTH SITE #30 ONE-MONTH POST PLACEMENT. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24815502 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. LACK OF INTEGRATION. UNKNOWN TOOTH NUMBER. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, SORENESS AND SWELLING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Unspecified Infection
MAUDE report 24758195 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO BONE LOSS. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24734878 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POST-OP APPOINTMENT FOR THE IMPLANT AT TOOTH SITE #30 AND THE DOCTOR FOUND PROMINENT BONE LOSS. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24598528 ↗MalfunctionMar 9, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24549008 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT MOBILITY AND BONE LOSS AROUND THE IMPLANT NOTED AT A FOLLOW-UP VISIT SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24520602 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS PAIN AND BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH LOCATION WAS NOT PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24489338 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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