Tapered Screw-Vent® TSVWH13Recalls & 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 is a ZimVie Tapered Screw-Vent TSVWH13 endosseous dental implant, a screw-shaped root-form implant placed in the jawbone. Most of the 58 reports describe implants that failed or had to be removed, with peri-implantitis (gum and bone infection), bone loss, and a few fractures of the implant or surrounding bone. The reports mention no deaths and 55 injuries, and three malfunction reports. No recalls name this device. In the last 12 months there were 2 reports, down from 14 in the previous 12 months.
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
- 57
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00889024020115), received between Jan 10, 2020 and Jan 29, 2026 — classified as 54 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 Problem49
- Fracture5
- Mechanical Problem3
- Loss of Osseointegration1
Patient problems
- Unspecified Infection36
- Osteolysis28
- Inflammation13
- No Code Available10
- Pain9
- No Clinical Signs, Symptoms or Conditions6
- No Information6
- Erosion4
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Fistula; Osteolysis; Unspecified Infection
MAUDE report 24209568 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #36 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23359521 ↗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 #6 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22585795 ↗InjuryJun 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 #14 WAS REMOVED DUE TO BONE LOSS. IT WAS NOTED THAT THERE WAS A PERFORATION OF THE SINUS, WHICH WAS CONFIRMED DURING COMPUTED TOMOGRAPHY IMAGING. IT WAS ADDITIONALLY NOTED THAT THERE WAS A FISTULA ON THE THE BUCCAL WITH POSITIVE SUPPURATION UPON PALPATION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Sinus Perforation
MAUDE report 22303022 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #17 & UNKNOWN FAILED, DUE TO PERI-IMPLANTITIS.
Patient problems: Erosion; Fistula; Osteolysis; Unspecified Infection
MAUDE report 22294452 ↗InjuryJun 19, 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: Erosion; Fistula; Osteolysis; Unspecified Infection
MAUDE report 22294432 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE BUCCAL BONE BROKE DURING IMPLANT PLACEMENT AT TOOTH LOCATION #4. THE IMPLANT WAS REMOVED. THE PATIENT DID NOT WANT GRAFTING.
Patient problems: Bone Fracture(s)
MAUDE report 22071316 ↗InjuryApr 17, 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 BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21860310 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD DEBRIDEMENT DONE BEFORE THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21571688 ↗InjuryMar 11, 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; Unspecified Infection
MAUDE report 21571684 ↗InjuryMar 11, 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. (B)(6) 2023 PATIENT PRESENT IN OFFICE AND HAS SWELLING OF GUMS AROUND IMPLANT. PATIENT STATES SHE HAS HAD SOME BLEEDING AND ON (B)(6) 2024 SHE HAD DRAINAGE FROM THE AREA. BONE LOSS AROUND IMPLANTS NOTED. DISCUSSED HX OF SMOKING. PLAN DEBRIDEMENT. (B)(6) 2024 DEBRIDED IMPLANT USING ROTARY BRUSH AND CITRIC ACID. (B)(6) 2024, PATIENT STATES SHE HAS STOPPED SMOKING. IMPLANT HAS DEEP PROBING DEPTHS. DECISION WAS MADE TO REMOVE IMPLANT. (B)(6) 2024 IMPLANT REMOVED AND GRAFTED. (B)(6) 2024, FOLLOW UP APPT FROM REMOVAL. PATIENT DECIDED TO REPLACE WITH A PARTIAL DENTURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21571495 ↗InjuryMar 11, 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; Unspecified Infection
MAUDE report 21571381 ↗InjuryFeb 26, 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 #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT; PAIN, SWELLING AND PARESTHESIA.
Patient problems: Paresthesia; Swelling/ Edema; Unspecified Infection
MAUDE report 21470918 ↗InjuryFeb 26, 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 #27 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 21469479 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 6 WAS REMOVED DUE TO PERIIMPLANTITIS. CUSTOMER REPORTED PAINFUL THROUGHOUT THE HEALING PROCESS. DID NOT TORQUE, INSTEAD IT CAME OUT AT TORQUE TEST FOLLOW UP. PROCEDURE WAS NOT COMPLETED AND ADDITIONAL APPOINTMENT IS REQUIRED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20923712 ↗InjuryMay 7, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED, THAT THE IMPLANT AT TOOTH SITE #20 HAD DAMAGED THREADS. THE IMPLANT DID NOT THREAD AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260065 ↗InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED COMPLAINING OF SWELLING AND PAIN AROUND THE IMPLANT AT TOOTH LOCATION #4. UPON X-RAY, BONE LOSS WAS NOTED AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Pain
MAUDE report 19230177 ↗InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS AN IMMEDIATE ON (B)(6) 2023 TOOTH #13, WHEN EXAMINED ON (B)(6) 2024 PT. HAD A BUCCAL ABSCESS AND INFLAMMATION, INTEGRATED WITH BUCCAL BONE LOSS REMOVAL OF IMPLANT ON (B)(6) 2024.
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 18779385 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18727511 ↗InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS WITH PAIN AND POCKETING DUE TO BIOLOGICAL FAILURE OF THE IMPLANT, WHICH WAS REMOVED. TOOTH LOCATION IS UNKNOWN.
Patient problems: Osteolysis; Pain
MAUDE report 17028510 ↗InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AND EDEMA AT TOOTH SITE #4; THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 17010870 ↗InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #28 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 16330521 ↗InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT IN SITE 4 WAS REMOVED DUE TO PERI IMPLANTITIS BONE LOSS AND INFECTION NOTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16253026 ↗InjuryJan 23, 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16225131 ↗InjuryJan 6, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 16117451 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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