Tapered Screw-Vent® TSVM6B8Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent dental implant is a root-form implant placed in the jaw to hold a tooth replacement. Reports mostly describe infection around the implant with bone loss and loosening, often leading to removal of the implant, and a few fractures. There are 23 reports that name its identifier, mentioning 22 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
- 22
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024019713), received between Jul 3, 2020 and Mar 2, 2026 — classified as 21 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture2
- Separation Failure1
Patient problems
- Unspecified Infection18
- Inflammation10
- Osteolysis8
- Pain8
- No Clinical Signs, Symptoms or Conditions3
- Sinus Perforation1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT AT TOOTH SITE #19 PLACED AND WAS HAVING SOME DISCOMFORT WITH THE IMPLANT. THE PATIENT CAME IN FOR A RECHECK APPOINTMENT AND STATED THAT THE IMPLANT HAD FALLEN OUT. THE IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24490615 ↗InjuryJan 22, 2026Adverse 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 24147623 ↗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 #3 WAS REMOVED DUE TO INFECTION AND TENDERNESS AT THE REGION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23782605 ↗InjurySep 9, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS FRACTURED. THE IMPLANT WAS REMOVED AND THE PATIENT WAS PLACED ON AN ANTIBIOTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000602 ↗InjuryJul 21, 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 BONE LOSS AND INFECTION. PREVIOUS RCT-TOOTH, WHICH HAD LARGE PERIAPICAL INFECTION AND SUBSEQUENT SINUS INFLAMMATION EXTRACTED AND GRAFTED. IMPLANT SURGERY COMPLETED WITH CONCURRENT GRAFTING. UNDERWENT HEALING. AT TIME OF UNCOVER, BUCCAL DEHISCENCE NOTED WITH VERY LITTLE REVERSE TORQUE, IMPLANT WAS EXPLANTED UNEVENTFULLY. PATIENT WILL BE OPTING FOR TRADITIONAL FIXED DENTURE. TOOTH SITE: 3. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22553640 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #13, #14, AND #15 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22303269 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #18 AND #19 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22213105 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTION ON EXAM #18 WAS REPORTED. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20537365 ↗InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UPON EXAMINATION OF THE IMPLANT AT TOOTH SITE #18, INFECTION WAS DISCOVERED. THE IMPLANT WAS THEN REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 19920282 ↗InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT STATED HAVING PAIN AROUND IMPLANT AT TOOTH SITE #31, IMPLANT WAS THEN REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19841965 ↗InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY PHONE THAT HE IMPLANT IN SITE 31 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT STATED SHE HAD BEEN HAVING PAIN AROUND IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19722331 ↗MalfunctionJun 28, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #18 WAS PLACED INTO THE OSTEOTOMY AND TORQUED INTO POSITION. THE DOCTOR WAS THEN UNABLE TO REMOVE THE FIXTURE MOUNT FROM THE FIXTURE. THE IMPLANT WAS NOT OVER-TORQUED. THE IMPLANT HAD TO BE REMOVED AND WAS REPLACED WITH A DIFFERENT ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19634441 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED INFECTION ON TOOTH 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19320438 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IMPLANT WAS RETRIEVED DUE TO INFECTION. TOOTH # 19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 19293931 ↗InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE EVENT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18541935 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING INVESTIGATION, IT WAS CONFIRMED THAT THE IMPLANT WAS NOT RETURNED.
Patient problems: Unspecified Infection
MAUDE report 18164370 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 BECAME INFECTED AND WAS REMOVED. BONE GRAFT AND MEMBRANE PLACED.
Patient problems: Unspecified Infection
MAUDE report 16811564 ↗InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 16531621 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 16198046 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT ON TOOTH SITE #14 WAS REMOVED DUE TO SINUS PERFORATION. SYMPTOMS OF THE EVENT: SINUSITIS, INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain; Sinus Perforation
MAUDE report 15431022 ↗InjuryApr 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT BIT DOWN ON A NUT AND FRACTURED THE IMPLANT AT TOOTH LOCATION #18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14052524 ↗InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT (TSVM6B8) WAS REMOVED DUE TO SEVERE PAIN AND POSSIBLE INFECTION AT TOOTH LOCATION 30.
Patient problems: Pain; Unspecified Infection
MAUDE report 10228457 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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