Tapered Screw-Vent® TSVMB10Recalls & 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 has 233 adverse event reports, including 224 injuries and no deaths. The reports mostly describe inflammation and bone loss around the implant (peri-implantitis), often leading to its removal. Unspecified infection is listed in 129 reports, and osteolysis (bone loss) in 103. 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
- 232
- Deaths reported
- 0
- Injuries reported
- 223
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 00889024019720), received between Oct 11, 2019 and Sep 17, 2026 — classified as 223 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 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 Problem190
- Fracture31
- Component Missing3
- Patient-Device Incompatibility3
- Mechanical Problem2
- Separation Failure2
- Loss of Osseointegration1
- Packaging Problem1
Patient problems
- Unspecified Infection128
- Osteolysis101
- Inflammation47
- No Clinical Signs, Symptoms or Conditions44
- Pain44
- No Information13
- Swelling/ Edema9
- Discomfort7
Recent adverse event reports
The 25 most recent of 232 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to an infection.Inflammation and tenderness reported as a consequence. Tooth site 29.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50798646 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to peri-implantitis. Implant was placed on (b)(6) 2025, surgery went well during intervention, stitches were removed after 7 days but later on there was peri-implantitis. Patient referred pain.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50264958 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED PARULIS WITH DRAINAGE ADJACENT TO THE BUCCAL ALVEOLUS SURFACE OF THE IMPLANT AT TOOTH SITE #12. IN ADDITION, BONE LOSS WAS NOTED MID-IMPLANT AT THE BUCCAL AND AT THE APEX WITH EROSION INTO THE SINUS. THE IMPLANT WAS REMOVED DUE TO SINUS PERFORATION, INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection
MAUDE report 25209782 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #44 WAS REMOVED DUE TO INFECTION WHEN STARTING SECOND SURGERY, 3 MONTHS AFTER IMPLANTATION. ANOTHER IMPLANT WAS PLACED IN A MORE DISTAL ZONE.
Patient problems: Unspecified Infection
MAUDE report 25172275 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT CAME TO CLINICIAN FOR A CHECK-UP; A PANORAMIC X-RAY IS TAKEN, REVEALING THAT THE IMPLANT HAS SUFFERED BONE LOSS AND PERI-IMPLANTITIS. THE BRIDGE IS REMOVED, EXPOSING THE IMPLANT, AND A HEALING ABUTMENT IS PLACED ON THE IMPLANT AT TOOTH 37, WHILST CLINICIAN WAITS FOR THE AREA TO REGENERATE SO THAT IT CAN BE RESTORED AGAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25147100 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE #37-42 WERE REMOVED DUE TO PERIIMPLANTITIS. PROCEDURE WAS COMPLETED WITH OTHER IMPLANTS. BONE TYPE: ILL.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25120885 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE #37-42 WERE REMOVED DUE TO PERIIMPLANTITIS. PROCEDURE WAS COMPLETED WITH OTHER IMPLANTS. BONE TYPE: ILL.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25120847 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION ON EXAM #20 AND TENDERNESS AT THE REGION. NOTED INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25031205 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25027495 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO A PERI-IMPLANTITIS, DETECTED DURING LOCATOR PLACEMENT. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24951594 ↗MalfunctionApr 9, 2026Separation Failure
IT WAS REPORTED THAT THE IMPLANT COULD NOT BE DISENGAGED FROM THE MOUNT AND COULD NOT BE PLACED. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828806 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24800485 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #43 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 24800362 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24783644 ↗InjuryApr 3, 2026Adverse 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: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24781651 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON EXAM, THERE WAS INFECTION AND TENDERNESS AROUND THE REGION OF THE IMPLANT AT TOOTH SITE #5. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24648284 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #35 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24500700 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #41 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24339925 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24327159 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS REMOVED DUE TO A PERI IMPLANTITIS AT TOOTH SITE #1.2 PATIENT REFERRED IMPLANT MOBILITY AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24265878 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO A SINUS PERFORATION. PROCEDURE WAS NOT COMPLETED.
Patient problems: Sinus Perforation
MAUDE report 24265642 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #36+37 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24257608 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #36+37 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24257590 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GENERAL DENTIST REMOVED THE CROWN FROM THE IMPLANT AT TOOTH SITE #4 TO SEE WHAT WAS CAUSING THE SWELLING. IT WAS NOTED THAT THE AREA AROUND THE IMPLANT WAS INFECTED. THE IMPLANT WAS NOT REMOVED. THE CUSTOMER PRESCRIBED ANTIBIOTICS, DEBRIDED THE AREA, REMOVED GRANULATION TISSUE THAT WAS FOUND, IRRIGATED THE SITE WITH CHLORHEXIDINE AND REPLACED THE FLAP AND SUTURED. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 24168727 ↗InjuryJan 23, 2026Adverse 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 24168422 ↗
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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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