Tapered Screw-Vent TSV4B11Recalls & 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. Its 368 reports include 333 injuries and no deaths, and mostly describe implants removed after peri-implantitis, infection or bone loss, with pain and inflammation also listed. Some reports mention fractured implant collars. 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
- 371
- Deaths reported
- 0
- Injuries reported
- 336
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 371 adverse event reports that list this exact device (DI 00889024019232), received between Aug 29, 2019 and Sep 29, 2026 — classified as 336 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (74 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 Problem268
- Fracture74
- Component Missing9
- Separation Failure8
- Patient-Device Incompatibility5
- Detachment of Device or Device Component3
- Mechanical Problem3
- Packaging Problem3
Patient problems
- Unspecified Infection180
- Osteolysis128
- No Clinical Signs, Symptoms or Conditions90
- Pain80
- Inflammation67
- No Information39
- No Code Available27
- Abscess18
Recent adverse event reports
The 25 most recent of 371 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
It was reported the patient received a 4.1 × 11.5 mm implant in 2018. They recently returned for a follow-up due to discomfort; images revealed a fracture in the implant, and it was subsequently removed. No harm to patient
Patient problems: Discomfort
MAUDE report 50928419 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Discovered: During clinical procedure.Provide detailed description of problem: After an X-ray was taken by the general dentist, it was discovered that the implant at tooth site 13 was infected.Patient Impact: No harm to patient.Other Patient Impact: Preclude permanent impairment? No.If yes please explain:
Patient problems: Unspecified Infection
MAUDE report 50753039 ↗InjuryJul 29, 2026Fracture
It was reported implant fracture at tooth site 19 and was removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065308 ↗InjuryJul 28, 2026Fracture
It was reported that an implant was removed due to the implant fracture. Tooth site 36.Procedure was completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054477 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant was removed due to infection, which resulted in loss of osseointegration. The patient experienced an abscess and inflammation.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 50035129 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE INFECTION AND BONE LOSS. INFECTED IMPLANT- FAILED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25474142 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE DOCTOR PRESCRIBED ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25306506 ↗InjuryMay 26, 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 25285703 ↗InjuryMay 21, 2026Fracture
THE DOCTOR REPORTED AN UNSCREWED IMPLANT CROWN DUE TO A FRACTURE OF THE IMPLANT COLLAR. TOOTH LOCATION #46. IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240354 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO A PERI-IMPLANTITIS. CROWN WAS FITTED ON (B)(6) 2024 AND IMPLANT WAS MOBILE DURING THE EXAMINATION ON (B)(6) 2026.PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24937878 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24936478 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT THE MOMENT OF PLACING THE HEALING SCREW, INFECTION WAS NOTED AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 24885980 ↗MalfunctionApr 8, 2026Separation Failure
IT WAS REPORTED THE SCREW FROM THE MOUNT/TRANSFER COULDN'T BE REMOVED FROM THE IMPLANT AND THE IMPLANT WAS REMOVED. PROCEEDING WAS COMPLETED WITH ANOTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24814837 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 35 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PAIN AND INFLAMMATION REPORTED AS A CONSEQUENCE.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24637702 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. IMPLANT PLACED BY DR. WITH STERING TECHNIQUE WITH ASPIP PROTOCOL. CHX RINSE IODINE SERUB AMAZ 2000 MG. TOOTH # 2. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24631044 ↗InjuryMar 11, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 24568606 ↗InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO A FRACTURE AT THE IMPLANT COLLAR. DURING THE RE-EXAMINATION OF THE CT SCAN, A FRACTURE OF THE IMPLANT COLLAR WAS DETECTED.THE IRT FRACTURED AT THE TIP WHILE REMOVING THE FRACTURED IMPLANT. PROCEDURE WAS COMPLETED. THIS COMPLAINT REFERS TO THE IMPLANT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24517056 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO INFECTION AND BONE LOSS TWO WEEKS AFTER THE IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24389474 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24160498 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24118864 ↗InjuryJan 9, 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 24022045 ↗InjuryDec 11, 2025Fracture; Fracture
ZIMVIE EMPLOYEE REPORTS THROUGH EMAIL THAT THE CLINIC INFORMED THEM OF A FRACTURED IMPLANT AT THE HEAD PART, AND THE IMPLANT WAS REMOVED. IT WAS REPORTED THAT THE IMPLANT HAD MOBILITY AND THAT THEY DISCOVERED THROUGH AN RX THAT IT WAS DUE TO IMPLANT FRACTURE. THEY ALSO INDICATE THE IMPLANT WAS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776505 ↗InjuryDec 3, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #46 FRACTURED AT THE CONNECTION AND HAD TO BE REMOVED. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE. PATIENT EXPERIENCED BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23702843 ↗InjuryNov 24, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638848 ↗InjuryNov 20, 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: Inflammation; Pain; Unspecified Infection
MAUDE report 23605171 ↗
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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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