Tapered Screw-Vent® TSV6H8Recalls & 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 dental implant is a root-form implant used to replace missing teeth. Most of the 44 reports describe implants that loosened or were removed because of infection around the implant (peri-implantitis) and loss of supporting bone, along with pain and inflammation; a few mention the implant or its component breaking or separating. There are 43 injuries and no deaths. No recalls name this device, and the number of reports is steady at 5 over each of the past 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
- 44
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00889024019492), received between Sep 13, 2019 and May 19, 2026 — classified as 43 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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 Problem40
- Fracture3
- Separation Failure1
Patient problems
- Unspecified Infection27
- Osteolysis25
- Pain9
- Inflammation5
- No Information5
- No Code Available3
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND IT WAS REMOVED. THE PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25217596 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 24667519 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS FOUND TO BE MOBILE AT THE POST-OPERATIVE EXAMINATION. THE IMPLANT WAS REMOVED DUE TO INFECTION. THE BONE WAS GRAFTED AND EXPECTED TO BE REPLACED IN APPROXIMATELY THREE MONTHS USING A DIFFERENT BRAND.
Patient problems: Unspecified Infection
MAUDE report 24631183 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS PLACED BUT WAS MOBILE THREE WEEKS AFTER THE POST-OPERATIVE APPOINTMENT DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED AND AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24191857 ↗InjuryDec 13, 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 BONE LOSS. UNKNOWN TOOTH NUMBER.
Patient problems: Osteolysis
MAUDE report 23797758 ↗InjurySep 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 #3 HAD LOST INTEGRATION DUE TO PERIIMPLANTITIS AND WAS REMOVED. THE PATIENT DEVELOPED TENDERNESS. THE PATIENT PRESENTED TO HIS GENERAL DENTIST AND IMAGING CONFIRMED BONE LOSS AROUND THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23074781 ↗InjurySep 2, 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 #15 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 22936260 ↗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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS REMOVED AFTER AGGRESSIVE HYGIENE DID NOT MAKE IT ANY BETTER. STILL BLEEDING ON PROBING. AREA CURETTED AND COPIOUSLY IRRIGATED WITH STERILE SALINE. CORTICAL PUROS WAS PACKED INTO THE SOCKET. COLLAPLUG PLACED AND SUTURED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22350112 ↗InjuryFeb 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 #3 WAS REMOVED DUE TO BONE LOSS AND INFECTION WHICH WAS DETECTED DURING IMAGING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21455024 ↗InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Swelling/ Edema
MAUDE report 21284015 ↗InjuryJun 4, 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; Pain; Unspecified Infection
MAUDE report 19460001 ↗InjuryMay 8, 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 #19 WAS REMOVED DUE TO PATIENT HAS ALWAYS HAD SORENESS AND ACHENES WITH THE IMPLANT SINCE PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 19269401 ↗InjuryMay 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO FRACTURED IMPLANT & PERI-IMPLANTITIS. PLATFORM WAS BROKEN, NUMBED TREPHINED. A TORQUE WRENCH WAS UTILIZED TO REMOVE THE IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19221524 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERI-IMPLANTITIS/BONE LOSS WAS REPORTED. IMPLANT MOBILE, REMOVED AND BONE GRAFTED. TOOTH #14.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18576228 ↗InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD POCKETING AND BLEEDING UPON PROBING AROUND THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Osteolysis; Unspecified Infection
MAUDE report 18487951 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT TOOTH SITE #19 AREA LINGUAL WAS BEING WORKED UP FOR MEDICATION-RELATED OSTEONECROSIS OF THE JAW (MRONJ), WHEN EXPLORATION WAS DONE IT WAS NOTED THAT IMPLANT AT TOOTH SITE #18 WAS COMPROMISED, THE PATIENT HAD EXPERIENCED BONE LOSS AT IMPLANT TOOTH SITE #18 AND IT WAS REMOVED. BONE WAS SUBMITTED FOR BIOPSY, CULTURE AND SENSITIVITY.
Patient problems: Osteolysis
MAUDE report 18416470 ↗InjuryDec 15, 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 AT IMPLANT TOOTH SITE #14, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED. SOCKET CURETTED AND INFLAMED, TISSUE REMOVAL. CORTAL PURUS POCKED, COLLAPLUG PLACED, SUTURED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18341341 ↗InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS. IMPLANT WAS REMOVED, PUROS WAS PLACE IN SOCKET. TOOTH #30.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18305598 ↗InjuryNov 30, 2023Adverse 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 18238588 ↗InjuryOct 6, 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 BONE LOSS. TOOTH SITE # 3 (UNIVERSAL).
Patient problems: Osteolysis
MAUDE report 17887180 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS FROM THE GENERAL DENTIST FOR PAIN IN THE AREA OF THE IMPLANT AT TOOTH LOCATION #14. THE IMPLANT REMAINED IMPLANTED. WE DETERMINED AFTER SEVERAL ATTEMPTS WITH GENERAL DENTIST AND TAKING CT SCAN AND X-RAYS THAT THE IMPLANT HAD FAILED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 17739023 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS FROM THE GENERAL DENTIST FOR PAIN IN THE AREA OF THE IMPLANT AT TOOTH LOCATION #14. THE IMPLANT REMAINED IMPLANTED. WE DETERMINED AFTER SEVERAL ATTEMPTS WITH GENERAL DENTIST AND TAKING CT SCAN AND X-RAYS THAT THE IMPLANT HAD FAILED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 17738880 ↗InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WENT FOR EVALUATION OF IMPLANT AT TOOTH SITE #14, THE PATIENT HAD PAIN IN THE AREA FOR A WHILE. THE PATIENT HAD DEVELOPED BONE LOSS AND INFECTION WITH ABSCESS AND INFLAMMATION. THE PATIENT'S DENTIST PRESCRIBED ANTIBIOTICS A COUPLE OF TIMES. THE IMPLANT WAS MOBILE AND HAD 9MM OF DEFECT. THE IMPLANT HAD FAILED AND WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17733884 ↗InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING CHECK-UP, THE IMPLANT AT TOOTH SITE #15 LOST INTEGRATION DUE TO PERIIMPLANTITIS AND WAS REMOVED. THE AREA WAS CLEANED AND ALLOGRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17105649 ↗InjuryMar 8, 2023Adverse 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; Unspecified Infection
MAUDE report 16501428 ↗
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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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