Tapered Screw-Vent® TSV6B10Recalls & 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 implant is a root-form dental implant placed in the jawbone to hold a replacement tooth. Its 153 reports often describe infection and bone loss around the implant, and some implants were removed. The reports include no deaths and 141 injuries, and 12 are malfunctions. 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
- 152
- Deaths reported
- 0
- Injuries reported
- 140
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00889024019379), received between Oct 18, 2019 and Jun 5, 2026 — classified as 140 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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 Problem121
- Fracture16
- Patient-Device Incompatibility5
- Separation Failure5
- Mechanical Problem3
- Detachment of Device or Device Component2
- Component Missing1
- Failure to Eject1
Patient problems
- Unspecified Infection80
- Osteolysis64
- Pain47
- No Clinical Signs, Symptoms or Conditions31
- Inflammation29
- No Information12
- Abscess9
- Hypersensitivity/Allergic reaction8
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT WAS ORIGINALLY PLACED IN 2024. ON (B)(6) 2026, THE IMPLANT FRACTURED AND DUE TO THE COMPLICATION, IT WAS REMOVED. TOOTH NUMBER 30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 25407182 ↗InjuryMay 19, 2026Adverse 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: PAIN AND ABSCESS.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25221389 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24945024 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO BONE LOSS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: Osteolysis
MAUDE report 24725912 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO INFECTION. ON (B)(6) 2026, THE PATIENT HAD AN EXTRACTION PROCEDURE OF THE IMPLANT AT TOOTH SITE #18 WITH IMMEDIATE IMPLANT REPLACEMENT, BONE GRAFTING AND PRP. THE PATIENT PRESENTED ON (B)(6) 2026 WITH SIGNIFICANT FACIAL SWELLING. THE IMPLANT APPEARED INFECTED. IT WAS REMOVED AND THE SITE WAS DEBRIDED. THE PATIENT WAS PRESCRIBED AMOXICILLIN 500 MG. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24570428 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO LOOSENESS ASSOCIATED WITH BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24446698 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24308331 ↗InjuryFeb 4, 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 24261978 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION. BONE GRAFT PLACE IN AREA #14. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 24081144 ↗InjuryJan 14, 2026Fracture; Failure to Eject
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 FRACTURED AND WAS REMOVED.
Patient problems: Headache; No Clinical Signs, Symptoms or Conditions
MAUDE report 24072532 ↗MalfunctionJan 14, 2026Separation Failure
IT WAS REPORTED THAT IMPLANT DOES NOT DISENGAGE/RELEASE. IMPLANT WAS PLACED BUT THE MOUNT WAS STUCK. TOOTH SITE # 13. PROCEDURE COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069359 ↗InjuryJan 8, 2026Fracture
DURING PRODUCT EVALUATION, ADDITIONAL INFORMATION WAS PROVIDED THAT CONFIRMED THAT THIS CASE IS A DUPLICATE OF MFR 0001038806-2026-00082. AS A RESULT, THE PRIOR SUBMISSIONS FOR MFR-0001038806-2026-00133 SUBMITTED ON JANUARY 8, 2026 IS NO LONGER CONSIDERED A REPORTABLE EVENT BY ZIMVIE AND NO FURTHER REPORTS WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24012566 ↗InjuryJan 7, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED. PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE, PLACED NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988721 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23973668 ↗InjuryDec 17, 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: Osteolysis
MAUDE report 23827822 ↗InjuryDec 8, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23736298 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PERI-IMPLANTITIS. ON (B)(6) 2020, THE IMPLANT WAS PLACED TO AREA OF MISSING TOOTH SITE # (B)(6). PATIENT RETURNED FOR POST OP VISITS ON (B)(6) 2020 AND (B)(6) 2020. HEALING WITHIN NORMAL LIMITS, AS SUCH, IMPLANT EXPOSED, TORQUED TESTED AND FULLY RESTORED ON (B)(6) 2020. PATIENT RETURNED ON (B)(6) 2025 QUESTIONING THE STABILITY OF THE IMPLANT. IT APPEARED TO HAVE LOST INTEGRATION DUE TO BONE LOSS AND OR BONE DENSITY AND POOR HYGIENE. THE IMPLANT WAS REMOVED AND SITE DEBRIDED AND PACKED WIT COLLAGEN PLUG ONLY. THE IMPLANT WAS REMOVED AND A COLLAGEN PLUG WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, LOSS OF INTEGRATION, LOOSENING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23468389 ↗InjuryNov 4, 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; Osteolysis; Unspecified Infection
MAUDE report 23464508 ↗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 #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23342826 ↗InjuryOct 17, 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. TOOTH SITE #17. PATIENT EXPERIENCED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23325467 ↗InjurySep 8, 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 FAILED TO OSTEOINTEGRATIE PROPERLY. THE IMPLANT WAS REMOVED AT TIME OF EXPOSURE/ STAGE 2. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22991303 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTEGRATED IMPLANT AT TOOTH SITE #30 SUFFERED PERI-IMPLANTITIS ON THE DISTAL, RESULTING IN A DEFECT THE LENGTH OF THE IMPLANT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22926545 ↗InjuryAug 19, 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 #37 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22843576 ↗InjuryAug 4, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 22699133 ↗InjuryJul 8, 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: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection
MAUDE report 22441287 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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