Tapered Screw-Vent® TSVMB8Recalls & 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. Reports mostly describe infections leading to implant removal, sometimes with pain, swelling or abscess; other issues include bone loss and implant fracture. There are 79 reports: 71 injuries, 8 malfunctions and no deaths. There are no recalls naming this device. Reports in the last 12 months fell to 5 from 22 a year earlier.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00889024019768), received between Dec 11, 2019 and Aug 22, 2026 — classified as 72 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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 Problem62
- Fracture7
- Component Missing4
- Separation Failure2
- Detachment of Device or Device Component1
- Failure to Osseointegrate1
- Mechanical Problem1
- Packaging Problem1
Patient problems
- Unspecified Infection46
- Osteolysis34
- No Clinical Signs, Symptoms or Conditions20
- Pain19
- Inflammation17
- Swelling/ Edema5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Information3
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem
The doctor reports that the dental implant failed due to peri-implantitis. Implant was removed. Tooth site 26. The doctor reports in the PER that the procedure was not concluded by placing another implant. The doctor reported : Inflammation.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50386170 ↗InjuryMar 3, 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. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24500526 ↗MalfunctionJan 9, 2026Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018858 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain
MAUDE report 23838707 ↗InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Pain
MAUDE report 23757929 ↗InjuryDec 4, 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 #14 REACHED PRIMARY STABILITY BUT AFTER TWO MONTHS PATIENT CAME TO CLINIC, AND THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23716693 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. INFECTION ON EXAM #10 AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Unspecified Infection
MAUDE report 23086477 ↗InjurySep 9, 2025Fracture; Fracture
FOLLOW UP WAS DONE WITH CLINICIAN ON (B)(6) 2025 AND WAS ADVISED THAT THE PATIENT WAS REFERRED TO THE OFFICE WITH A FRACTURED IMPLANT COLLAR. PATIENT ARRIVED WITH A LOOSE CROWN AND WHEN PRIMARY DENTIST ASSESSED SITE, FOUND FRACTURED COLLAR. GENERAL DENTIST REMOVED ABUTMENT AND PLACED A HEALING COLLAR UNTIL REMOVAL. PATIENT SCHEDULED REMOVAL AFTER SHE GOT BACK FORM GOING OUT OF COUNTRY. IDENTIFIED ABUTMENT LOOSE WAS A FRACTURED COLLAR ON (B)(6) 2025. DELAYED REMOVAL (B)(6) 2025. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANT REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. GRAFTED: GRAFTED AT REMOVAL. BONE TYPE: UNKNOWN. TOOTH SITE: 30.
Patient problems: Inflammation
MAUDE report 23001279 ↗InjuryAug 29, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 22926195 ↗InjuryJul 14, 2025Fracture; Fracture
IT WAS REPORTED A FRACTURE OF THE UPPER PART OF THE IMPLANTS AT TOOTH SITES 34/36 OBSERVED DURING THE CLINICAL PROCEDURE. THE PROCESS WAS NOT COMPLETED WITH OTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation
MAUDE report 22492272 ↗InjuryJun 22, 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 (B)(6) WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22304576 ↗InjuryJun 16, 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 #18 AND #19 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22213163 ↗MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DOCTOR REPORTED THAT DURING SURGERY IMPLANT DISENGAGED FROM MOUNT AND FELL DOWN. ANOTHER IMPLANT WAS PLACED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027762 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO EXTENSIVE BONE LOSS # 20. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21986350 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO EXTENSIVE BONE LOSS #19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21986144 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #4 AND #19 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, SWELLING AND PAIN.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 21873340 ↗InjuryMar 26, 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21698718 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT 4 TOOTH SITES AND THE IMPLANTS WERE REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21595577 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT 4 TOOTH SITES AND THE IMPLANTS WERE REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21595471 ↗InjuryFeb 5, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21316259 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #25 - 26. BOTH IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: IMPLANT MOBILITY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21262429 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #25 - 26. BOTH IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: IMPLANT MOBILITY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21262382 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. DOCTOR ALSO INDICATED NON-TRAUMATIC SINUS LIFT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21252791 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #35 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT AFTER REGENERATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21099887 ↗MalfunctionNov 28, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805568 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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