Tapered Screw-Vent® TSVB13Recalls & 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 ZimVie Tapered Screw-Vent dental implant is a root-form implant placed in the jawbone. Many of its 397 adverse event reports describe infection around the implant, bone loss and pain, and several describe implants being removed because of gum disease around them. The reports list 374 injuries and no deaths, and 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
- 403
- Deaths reported
- 0
- Injuries reported
- 380
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 00889024019522), received between Sep 11, 2019 and Sep 29, 2026 — classified as 380 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Fracture” (32 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 Problem350
- Fracture32
- Component Missing8
- Mechanical Problem7
- Separation Failure5
- Device Markings/Labelling Problem2
- Loss of Osseointegration2
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection254
- Osteolysis199
- Pain104
- Inflammation80
- No Clinical Signs, Symptoms or Conditions58
- No Code Available37
- No Information26
- Abscess24
Recent adverse event reports
The 25 most recent of 403 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant at tooth site 33 was removed due to bone loss.
Patient problems: Osteolysis
MAUDE report 50934695 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported apical abscess on implants, causing bone loss. Tooth sites 32 and 42. Infection was also reported.Procedure completed with another device.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50932122 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported apical abscess on implants, causing bone loss. Tooth sites 32 and 42.Procedure completed with another device.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50931992 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #33 was removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50769245 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 34 was removed due to an extensive infection and significant bone loss.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50754916 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported significant bone loss due to peri implantitis, tooth sites 13 and 14.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50692016 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with Grade II mobility of an IS bridge. Radiographic examination revealed significant bone loss. Clinical examination showed exposure of the implant threads. The patient was diagnosed with peri-implantitis. It was decided to remove the implants in order to perform guided bone regeneration (GBR) and subsequently place new implants. Tooth sites 11, 13, 22 and 23.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50690870 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that peri-implantitis was identified at implant sites 12, 22, 15, 25, and 32 during a clinical procedure. The affected implants were removed, and no harm to the patient was reported.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50516488 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with mobility of the anterior bridge. The implants at tooth sites 12 and 21 were removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50138892 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #15 AND #23 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25444964 ↗InjuryJun 2, 2026Adverse 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 25363438 ↗InjuryMay 27, 2026Adverse 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 AND ABSCESS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25300910 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25279797 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE # 13.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25231006 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS, BONE LOSS, LOSS INTEGRATION. IMPLANT FAILED FOR PERI-IMPLANTITIS POST RESTORATION, REMOVED DUE TO 50% BONE LOSS. TOOTH SITE # 42. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25230594 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 45 WAS REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25121381 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AROUND THE IMPLANT AT TOOTH SITE #21. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25104491 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 24713493 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE # 36.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24686304 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. IMPLANT IN UNKNOWN SITE BECAME MOBILE AND WAS REMOVED. SYMPTOMS: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24685860 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO INFECTION AND BONE LOSS. THE PATIENT RETURNED ON (B)(6) 2014 FOR THE PLACEMENT OF IMPLANT AT TOOTH SITE #13. SUBSEQUENT EXAMINATIONS ON (B)(6) 2014 NOTED THAT ALL HEALING WAS WITHIN NORMAL LIMITS, AS SUCH IMPLANT WAS RESTORED ON (B)(6) 2014. THE PATIENT RETURNED ON (B)(6) 2026 COMPLAINING OF PAIN AND A POSSIBLE INFECTION. X-RAY IMAGING CONFIRMED BONE LOSS. THE IMPLANT WAS REMOVED AND THE SITE WAS DEBRIDED. THE PATIENT STARTED ON AMOXICILLIN 500 MG. THE PATIENT ANTICIPATED RETURNING ON (B)(6) 2026 FOR A RE-EVALUATION OF A FUTURE BONE GRAFT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24569995 ↗MalfunctionMar 10, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT THE IMPLANT THAT THE CUSTOMER RECEIVED HAD THE CORRECT LABEL ON THE BOX AND THE IMPLANT VIAL, BUT THAT THE TOP STICKER WAS LABELED AS A 4.1 X 8MM DEVICE, BUT THAT THE IMPLANT WAS A 3.7 X 13MM DEVICE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE. THE DEVICE HAD BEEN PLACED IN THE PATIENT'S MOUTH. THE DEVICE WAS REMOVED DURING THE SURGERY PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561476 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. FISTULA WAS REPORTED.
Patient problems: Fistula; Osteolysis; Unspecified Infection
MAUDE report 24499600 ↗MalfunctionFeb 27, 2026Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474334 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. LOSS INTEGRATION. MOBILITY ALSO REPORTED. TOOTH SITE # 45.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24469055 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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