Tapered Screw-Vent® TSVTB11Recalls & 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 is a root-form implant placed in the jawbone. The 446 reports often describe implants failing because of gum and bone disease around them, such as bone loss and infection, and some describe implants fracturing or crowns coming loose. There are 428 injuries and no deaths. One recall, about vial caps on some implant lots that may crack during manufacturing, began in November 2017 and is closed.
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
- 439
- Deaths reported
- 0
- Injuries reported
- 421
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 00889024019935), received between Jul 26, 2019 and Sep 15, 2026 — classified as 421 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (45 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Nov 20, 2017Class IITerminated
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Z-0284-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem371
- Fracture45
- Separation Failure9
- Component Missing8
- Unsealed Device Packaging3
- Detachment of Device or Device Component2
- Loss of Osseointegration2
- Packaging Problem2
Patient problems
- Unspecified Infection254
- Osteolysis183
- Pain112
- No Clinical Signs, Symptoms or Conditions83
- Inflammation80
- Abscess34
- Erosion31
- Swelling/ Edema22
Recent adverse event reports
The 25 most recent of 439 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Fracture
It was reported that the implant at tooth site #19 fractured and was subsequently removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771390 ↗InjuryAug 7, 2026Fracture
It was reported that crown was lose and implant was fractured. Tooth site 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169795 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the dental implants at Tooth Sites 23 and 25 failed due to peri-implantitis. Pain was also reported.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50051882 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the dental implants at Tooth Sites 23 and 25 failed due to peri-implantitis. Pain was also reported.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50051880 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #29 was removed due to an infection.
Patient problems: Unspecified Infection
MAUDE report 50033832 ↗InjuryJul 27, 2026Fracture
Doctor reported fracture of implant collar at tooth site 46, fitted with a porcelain-fused-to-metal crown on HLA 3/4 abutment. Doctor also indicated crown loss, a new zircon crown will be placed at tooth site 46. Implant was removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50018220 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED AFTER IMPLANT PLACEMENT WITH ERYTHEMA, TENDERNESS TO PALPATION, INFECTION AND PURULENT EXUDATE IN THE UPPER RIGHT IMPLANT SITE AT TOOTH LOCATION #5. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR FOURTEEN (14) DAYS WITH PAIN MEDS. THE PATIENT RETURNED FOR DEBRIDEMENT AND IMPLANT REMOVAL DUE TO ALLERGIC REACTION AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection
MAUDE report 25477215 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 29 WAS LOOSE AND HAD BONE LOSS.
Patient problems: Osteolysis
MAUDE report 25284253 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME TO CLINICIAN REFERRING MOBILITY, WHEN TAKING X-RAYS, THE DOCTOR NOTICED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE 21 AND IT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25186188 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS CAUSING A LOOSE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Osteolysis; Pain; Swelling/ Edema
MAUDE report 24957916 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRAIRATIC PROGRESSIVE BONE LOSS WAS NOTED AT THE IMPLANTS AT TOOTH SITES #19, #20 AND #21 AND WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 24769754 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. CLINICIAN REPORTED THAT DURING CLINICAL EXAM #11 HAD MOBILITY AND LOSS OF INTEGRATION WAS REMOVED IMMEDIATELY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24673670 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 DID NOT INTEGRATE AND WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24592931 ↗InjuryMar 6, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE PLACING IMPLANT THE IMPLANT REQUIRED TO BE TIGHTENED IN PLACE USING A HAND DRIVER. WHILE ATTACHED, IMPLANT TO MOUNT, THE IMPLANT WAS NOT FULLY ENGAGE. IT CAME OUT AND FELL ON THE FLOOR. NOTED IMPLANT CAME OFF IMPLANT MOUNT AND FELL ON THE FLOOR. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT. WILL REPLACE IMPLANT IN 3 MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532536 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINING FISTULA FACIAL TO THE IMPLANT AT TOOTH SITE #8. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: FISTULA, ABSCESS AND PAIN.
Patient problems: Abscess; Fistula; Unspecified Infection
MAUDE report 24497580 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO INFECTION. THE PATIENT REPORTED A THROBBING SENSATION AT STAGE II CHECK. A SMALL BUCCAL FISTULA WAS NOTED. THE IMPLANT WAS STABLE, NOT MOBILE TO TORQUE. THE SOFT TISSUE AND FISTULA WAS DEBRIDED. THE IMPLANT THREADS WERE COVERED BY BONE, BUT GRANULATION TISSUE NOTED BETWEEN THE OUTER CORTEX OF BONE AND THE IMPLANT. THE SITE TISSUE WAS DEBRIDED AND THE SITE WAS IRRIGATED THOROUGHLY. THE REGION OF GRANULATED TISSUE REMOVAL WAS AUGMENTED WITH A GRAFT. THREE WEEKS LATER THE SYMPTOMS AND CLINICAL PICTURE IMPROVED BUT THE BUCCAL FISTULA RETURNED AND THE PATIENT BEGAN TO FEEL INTERMITTENT THROBBING AGAIN. UPON RE-OPENING THE LIFT A PORTION OF THE BONE GRAFT TOOK AND THE HAD REFORMED. THIS TIME TOWARD THE APEX. THE IMPLANT WAS REMOVED DUE TO THE PATHOLOGY. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, FISTULA AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24460380 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24421466 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24370551 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24370501 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24370442 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24370293 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24370188 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24369991 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT DID NOT INTEGRATE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24368085 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24349836 ↗
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- 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 · each recall links to the FDA recall notice
- 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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