Tapered Screw-Vent® TSVWB11Recalls & 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 screw-shaped dental implant placed into the jawbone. Many of the 313 reports describe implants being removed because of infection or bone loss around them, and some describe fractured implants. There were 283 injury reports 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
- 312
- Deaths reported
- 0
- Injuries reported
- 282
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 00889024020054), received between Oct 4, 2019 and Sep 14, 2026 — classified as 282 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Fracture” (52 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 Problem235
- Fracture52
- Mechanical Problem9
- Separation Failure8
- Patient-Device Incompatibility4
- Component Missing3
- Loss of Osseointegration2
- Disconnection1
Patient problems
- Unspecified Infection167
- Osteolysis124
- Pain81
- No Clinical Signs, Symptoms or Conditions77
- Inflammation69
- Abscess17
- Swelling/ Edema14
- No Code Available13
Recent adverse event reports
The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Discovered : During clinical procedure.Provide detailed description of problem : It was reported that the patient presented for implant uncovery, at which time approximately 50% bone loss was discovered around the implant at tooth site 30. The implant was removed, the site was curetted, and a bone graft was placed.Patient Impact : No harm to patient.
Patient problems: Osteolysis
MAUDE report 50753539 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT CAME IN FOR 1 YR CHECK FOLLOWING HIS FINAL RESTORATION PLACEMENT WITH GD AND IMPLANT HAD PERI-IMPLANTITIS AND MOBILITY. IMPLANT WAS REMOVED AT THAT TIME. SYMPTOMS: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25448078 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25435539 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25433483 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25300104 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25285595 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO A BONE LOSS AND AN INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25041595 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. MODERATE BONE LOSS, PERI-IMPLANTITIS #14. BONE GRAFTED THE AREA AND LEAVING IT TO HEAL. PATIENT WILL HAVE 2 WEEK POST OP TO FOLLOW UP.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24925201 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED AFTER A SINUS LIFT. TWO YEARS LATER, PERI-IMPLANTITIS DEVELOPED, AND BECAUSE OF AN INFECTION, THE IMPLANT HAD TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24806269 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24769558 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS AND SUBSEQUENT IMPLANT FAILURE AND MOBILITY.
Patient problems: Osteolysis
MAUDE report 24747649 ↗InjuryMar 26, 2026Fracture
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO FRACTURE. THE PATIENT CAME IN FOR A FLAP UNCOVER AREA TO SEE IF IMPLANT SITE 14 HAD INFECTION. IMPLANT WAS MOBILE. REMOVED CROWN AND DISCOVERED IMPLANT HEX WAS BROKEN. IMPLANT WAS REMOVED AND AREA WAS DEGRANULATED THE SOCKET. PREPPED FOR AN IMPLANT IN THAT AREA IN THE FUTURE. WILL LET AREA HEAL FOR 3 MONTHS BEFORE REIMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701905 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN DUE TO INFECTION PRESENT AROUND THE IMPLANT AT TOOTH SITE #28. EXAMINED THE AREA AND THE WHOLE IMPLANT WAS LOOSE. REMOVED THE CROWN AND IMPLANT AS A WHOLE AND DEGRANULATED THE AREA DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24690677 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS PLACED USING STERILE TECHNIQUE WITH ASEPTIC PROTOCOL AND CHX RINSE AND AMOXICILLIN, 2000MG GIVEN 1 HOUR PRIOR. THE IMPLANT AT TOOTH SITE #20 WAS NOTED WITH INFECTION AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24627155 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS PLACED ON (B)(6) 2015 AND WAS GRAFTED. DURING POST-OPERATIVE VISITS, WHICH TOOK PLACED ON (B)(6) 2015, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2016 HEALING WAS NOTED WITHIN NORMAL LIMITS. AS SUCH THE IMPLANT WAS RESTORED. THE PATIENT RETURNED ON (B)(6) 2025 WITH COMPLAINTS OF PAIN AND INFLAMMATION. THE IMPLANT APPEARED TO BE INFECTED AND WAS REMOVED. THE SITE WAS DEBRIDED AND THE BONE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24570309 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24524826 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24489818 ↗InjuryFeb 27, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468751 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24369009 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED DUE TO NERVE DAMAGE. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PATIENT FELT PAIN AND INFLAMMATION.
Patient problems: Inflammation; Nerve Damage; Pain
MAUDE report 24343328 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 35 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24307825 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME BACK WITH PAIN AND SIGNS IF PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH SITE #30. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24303997 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS CRESTAL BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #18. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 24267450 ↗InjuryJan 27, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187945 ↗MalfunctionJan 9, 2026Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 24018790 ↗
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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 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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