Tapered Screw-Vent® TSVTWH10Recalls & 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 TSVTWH10 is a root-form dental implant used to replace missing teeth. Most of the 30 reports describe implants that had to be taken out after infection, bone loss around the implant, or pain; a few mention the screw breaking or separating. There are 27 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
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024344341), received between Mar 3, 2020 and Aug 16, 2026 — classified as 27 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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 Problem24
- Fracture4
- Mechanical Problem1
- Separation Failure1
Patient problems
- Unspecified Infection13
- Osteolysis12
- No Clinical Signs, Symptoms or Conditions6
- Inflammation5
- Pain5
- Erosion4
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant failure appears to be related to peri-implantitis clinical and radiographic evaluation revealed significant peri-imlantitis, bone loss and inflammation around the implant, result mean loss of osseointegration. Implant was removed.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50264036 ↗InjuryMar 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. THIS AREA HAS HAD MULTIPLE FAILED IMPLANTS. HE CONTINUED TO HAVE INFECTION IN THIS AREA. THERE WAS A DELAY IN THE PROCEDURE. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24599793 ↗MalfunctionMar 9, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545859 ↗InjuryOct 31, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Unspecified Infection
MAUDE report 23436892 ↗InjuryOct 28, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 23404718 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS PLACED (B)(6) 2024 - PATIENT CALLED THE NEXT DAY, STILL NUMB - IMPLANT WAS REMOVED IMMEDIATELY WITH BONE GRAFT. TOOTH #20. (B)(6) 2024 - PATIENT CAME IN HAVING NUMBNESS LEFT SIDE. PA TAKEN - IMPLANT IS CLOSE TO NERVE. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 22436175 ↗InjuryMay 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 PAIN. IMPLANT WAS CAUSING PAIN TO PATIENT, TOOTH 31.
Patient problems: Pain
MAUDE report 22060819 ↗InjuryMay 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 PAIN. IMPLANT WAS CAUSING PAIN TO PATIENT, TOOTH 30.
Patient problems: Pain
MAUDE report 22060654 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT SHIFTED DISTALLY FOLLOWING PLACEMENT DUE TO COMPRISED BONE, POOR POSITION DUE TO BONE QUALITY. TOOTH 19. DISCOVERED FOLLOWING PLACEMENT. POOR POSITION DUE TO BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002439 ↗InjuryMay 4, 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 AND INFECTION, TOOTH SITE # 14. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21957269 ↗InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT #18 WAS PLACED ON (B)(6) 2024 AT SITE OF MISSING TOOTH. PATIENT RETURNED FOR POST OP VISITS ON (B)(6) 2024 AND (B)(6) 2024. THE IMPLANT WAS INFECTED AND REMOVED. THE SITE WAS DEBRIDED AND LEFT OPEN TO DRAIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21368354 ↗InjuryFeb 3, 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 INFECTION AND BONE LOSS. INFECTION PRESENT AROUND IMPLANT. REMOVED WITHOUT COMPLICATION. NOTED ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21293584 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT OM SITE 19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO. SITE GRAFTED: ALLOGRAFT PLACED PRIOR TO IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20532428 ↗InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD ACUTE IMPLANT FAILURE AROUND THE IMPLANT AT TOOTH LOCATION #19 DUE TO INFECTION. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, PAIN AND INFLAMMATION.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20506668 ↗InjuryOct 16, 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 #30 WAS REMOVED DUE TO INFECTION. INFECTION PRESENT SO IMPLANT WAS REMOVED WITHOUT COMPLICATION. SYMPTOMS: ABSCESS, INFLAMMATION.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 20467854 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED WITH HEMOSTATS DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19829549 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. INFECTION PRESENT AROUND IMPLANT - REVERSED IMPLANT & REMOVED EASILY. BONE GRAFT & MEMBRANE PLACED. DELAY DURING THE PROCEDURE, IMPLANT REMOVED, BONE. SYMPTOMS AS A RESULT OF THE EVENT: NONE INDICATED. ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 19519212 ↗MalfunctionApr 24, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO REMOVE THE MOUNT BECAUSE IT WAS STIFF. THE IMPLANT AT TOOTH LOCATION #3 WAS REMOVED AND AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175092 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis
MAUDE report 19132560 ↗InjuryJan 7, 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 PERI-IMPLANTITIS . TOOTH #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18461363 ↗InjuryJan 4, 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. INFLAMMATION, ABSCESS AND EDEMA ARE REPORTED SYMPTOMS. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR TO AND TOGETHER WITH THE ORIGINAL IMPLANT PLACEMENT.
Patient problems: Abscess; Inflammation; Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 16093864 ↗InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT RETURN WITH PAIN, IMPLANT REMOVED. TOOTH 11.
Patient problems: Pain
MAUDE report 14459361 ↗MalfunctionMar 25, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE THREADS OF THE IMPLANT ARE DAMAGED AND THE CUSTOMER IS REQUESTING A RETHREADING TOOL TO RETHREAD THE IMPLANT. TOOTH #14.
Patient problems: Failure of Implant
MAUDE report 13904879 ↗InjuryFeb 28, 2022Fracture; Fracture
IT WAS REPORTED THAT IMPLANT FRACTURED, LIKELY CAUSED FROM CLENCHING/GRINDING. TOOTH # 19. SYMPTOMS AS A RESULT OF THE EVENT: NONE INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625074 ↗InjuryDec 1, 2021Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 19 (UNIVERSAL) FRACTURED AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912699 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page