Tapered Screw-Vent® TSVMWB13Recalls & 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 TSVMWB13 is a root-form endosseous dental implant used as an anchor in the jaw. The 37 adverse event reports mostly describe implants being taken out after peri-implantitis, an infection around the implant, along with ongoing bone loss, pain, swelling and discharge; a few describe the implant or its collar fracturing. There were 34 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
- 36
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00889024019799), received between Apr 15, 2020 and May 14, 2026 — classified as 33 injuries, 3 malfunctions.
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 Problem1
- Unintended Movement1
Patient problems
- Unspecified Infection20
- Osteolysis13
- Pain9
- Inflammation8
- No Clinical Signs, Symptoms or Conditions8
- Swelling/ Edema4
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 24 AND 25 WERE REMOVED DURING WOUND EXAMINATION AFTER SURGERY DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. DOCTOR ALSO INDICATED PROGRESSIVE BONE LOSS DUE TO PERI-IMPLANTITIS SINCE 2022. DOCTOR PRESCRIBED TREATMENT WITH PERIOFLOW AND LIGOSAN GEL, THERE WAS PURULENT DISCHARGE ON (B)(6) 2024. LIGOSAN WAS USED AGAIN UNTIL EXTRACTION ON (B)(6) 2024.
Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 25168146 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 32 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANTS WERE PLACED DURING THE SAME PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24434458 ↗InjuryDec 11, 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 #19 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23782223 ↗InjuryAug 12, 2025Adverse 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 22781439 ↗InjuryJul 24, 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PLACEMENT OF THE #11 IMPLANT WAS NEAR THE LIGAMENT SPACE OF #10, WHICH THE CUSTOMER SPECULATED WAS A POSSIBLE REASON FOR THE FAILURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22588729 ↗InjuryJul 1, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT COLLAR AT TOOTH LOCATION #3 WAS FRACTURED. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 22372123 ↗InjuryJun 25, 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 PERI-IMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WAS REMOVED. TOOTH #5. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22331913 ↗InjuryJun 24, 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 PERIIMPLANTITIS. IMPLANT SHOWED EARLY SIGNS OF PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22324465 ↗InjuryMay 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118187 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20340982 ↗InjurySep 19, 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: Osteolysis
MAUDE report 20256265 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #5, WITH ASSOCIATED PAIN AND EDEMA. THE PATIENT WAS STARTED ON ANTIBIOTICS. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19131230 ↗InjuryApr 11, 2024Adverse 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & SWELLING.
Patient problems: Pain; Unspecified Infection
MAUDE report 19087096 ↗InjuryNov 29, 2023Adverse 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 18228653 ↗MalfunctionOct 25, 2023Fracture; Fracture
ON INSERTION OF IMPLANT AND PLACING VIA DRIVER AND TORQUE WRENCH, THE IMPLANT CARRIER FRACTURED AND PART OF IT REMAINED IN IMPLANT. THIS RESULTED IN THE IMPLANT BEING REMOVED AND REPLACED WITH ANOTHER IMPLANT. TOOTH #22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004070 ↗InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT THE PATIENT EXPERIENCED INFECTION. AT IMPLANT TOOTH SITE #18 WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 17867205 ↗InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #19, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 17867152 ↗InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED COMPLAINING OF PAIN AND SWELLING. THE IMPLANT AT TOOTH LOCATION #21 APPEARED INFECTED AND WAS REMOVED. THE SITE WAS DEBRIDED AND LEFT OPEN TO DRAIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 17413372 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME TO THE OFFICE WITH INFLAMMATION AND PAIN. CBCT SHOWS RL TO THE BUCCAL AND DISTAL OF THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED. IT APPEARS TO BE A METAL ALLERGY. THE SITE WAS DEBRIDED.
Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema
MAUDE report 17362102 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #30. THE PATIENT WAS PRESCRIBED MOTRIN 800MG AND THE IMPLANT REMAINED IMPLANTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 17361940 ↗InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PATIENT PRESENT ONE MONTH POST-OP VISIT. PUS WAS FOUND AND PATIENT FELT PAIN. ABSCESS IS REPORTED. IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH 30 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 16654657 ↗InjuryOct 24, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #14 WAS REMOVED DUE TO A FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663060 ↗InjuryOct 13, 2022Adverse 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 INFECTION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 15599918 ↗InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #12 WAS REMOVED DUE TO INFECTION. ABSCESS AND PAIN ARE REPORTED SYMPTOMS. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 14790813 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14695418 ↗
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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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