Tapered Screw-Vent® TSV4H11Recalls & 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 TSV4H11 is a root-form dental implant used to replace missing teeth. The 37 reports mostly describe implants taken out after infections, bone loss around the implant site, and inflammation; a few mention the implant or its head fracturing. All 37 reports involve 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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00889024019317), received between Nov 8, 2019 and Mar 24, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “Fracture” (5 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 Problem30
- Fracture5
- Mechanical Problem2
Patient problems
- Unspecified Infection17
- Osteolysis11
- No Clinical Signs, Symptoms or Conditions9
- Pain6
- Inflammation5
- No Information4
- Abscess2
- No Code Available2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682431 ↗InjuryDec 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678710 ↗InjuryOct 20, 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 #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23342414 ↗InjurySep 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960948 ↗InjuryAug 23, 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 #22, #30, AND #19 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22880353 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE CLEANING AND THE DENTIST NOTICED BONE LOSS AT TOOTH SITE #10. PATIENT WAS REFERRED TO AN ORAL SURGEON WHO CONFIRMED 10MM OF BONE LOSS AT THE IMPLANT SITE. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 22785052 ↗InjuryJun 27, 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 #UNK WAS REMOVED DUE TO INFECTION. ON (B)(6) 2024 NOTED ABSCESS ON FACIAL #12 IMPLANT. LARGE ABSCESS AT APEX OF IMPLANT AS WELL. REMOVED IMPLANT THAT DAY AND PLACED PUROS GRAFT. NEW IMPLANT PLACED (B)(6) 2025.
Patient problems: Unspecified Infection
MAUDE report 22349849 ↗InjuryApr 3, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #46 FAILED BECAUSE IT FRACTURED AT THE HEAD AND WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761689 ↗InjuryFeb 4, 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: Osteolysis
MAUDE report 21304147 ↗InjuryDec 30, 2024Adverse 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; Unspecified Infection
MAUDE report 21034470 ↗InjuryJul 26, 2024Mechanical Problem; Mechanical Problem
THE DOCTOR REPORTS THAT BOTH HEXAGONS ARE DAMAGED. IMPLANTS WERE REMOVED. PROCEDURE COMPLETED. AFFECTED BONE TYPE II AND DENTAL POSITIONS ARE 44 AND 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838564 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 35 AND 36 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH SWELLING. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 19713201 ↗InjuryJun 28, 2024Adverse 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; Pain; Unspecified Infection
MAUDE report 19634662 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO PAIN & PATIENT'S REQUEST. PATIENT CAME INTO OFFICE 20 DAYS POST OP WITH PAIN THAT SHE STATES IS PROGRESSING AND NOT GETTING BETTER. NO RELIEF WITH PAIN MEDS. PERCUSSION SENSITIVE. IMPLANT WAS STABLE AND NO SIGNS OF INFECTION. GRAFTED AREA FOR FUTURE IMPLANT
Patient problems: Pain
MAUDE report 19556949 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #6 WAS PLACED AND THREE (3) MONTHS LATER AND AT THE PATIENT'S CLEANING APPOINTMENT, THE PATIENT STATED THAT IT WAS TENDER AT THE APEX OF THE IMPLANT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 19213455 ↗InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 18853359 ↗InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 34 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18312999 ↗InjuryNov 29, 2023Adverse 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 #42 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18230569 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH 31 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17947999 ↗InjuryAug 23, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17602868 ↗InjuryJul 27, 2023Adverse 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: Osteolysis; Unspecified Infection
MAUDE report 17409951 ↗InjuryJul 20, 2023Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT AND ABUTMENT LOCATED IN POSITION NUMBER #36 FAILED BECAUSE THEY FRACTURED. THE IMPLANT FRACTURED AT THE HEAD AND THE ABUTMENT FRACTURED AT THE BODY. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17361845 ↗InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 14933786 ↗InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870804 ↗InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 12525083 ↗
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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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