Tapered Screw-Vent® TSVB11Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Tapered Screw-Vent is a root-form dental implant placed in the jawbone. Of the 603 reports naming it, many describe infections and bone loss around the implant, with some implants fracturing or failing to fuse with the bone. The reports include 561 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
- 605
- Deaths reported
- 0
- Injuries reported
- 563
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 605 adverse event reports that list this exact device (DI 00889024019515), received between Sep 11, 2019 and Sep 29, 2026 — classified as 563 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Fracture” (86 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem476
- Fracture86
- Separation Failure15
- Component Missing12
- Patient-Device Incompatibility7
- Unsealed Device Packaging7
- Mechanical Problem5
- Detachment of Device or Device Component2
Patient problems
- Unspecified Infection355
- Osteolysis252
- Pain152
- Inflammation109
- No Clinical Signs, Symptoms or Conditions106
- No Information44
- No Code Available39
- Abscess31
Recent adverse event reports
The 25 most recent of 605 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced a failed implant in 2024. A new implant was placed on (b)(6)2025, but the implant site became infected again. The implants were removed and debridement was performed on (b)(6)2025. Tooth site 11,21,25. Implants were removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931142 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931064 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 36 was removed due to an extensive infection and significant bone loss.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50754935 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abscess; Unspecified Infection
MAUDE report 50647711 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50647000 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
The implant at tooth site #11 was removed after the patient developed an infection three weeks after placement, accompanied by pain, edema, and inflammation.
Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50303324 ↗InjuryJul 31, 2026Fracture
It was reported that the implant was removed due to a fracture at the collar. The patient had received a prosthetic restoration that was not an original ZIMVIE product. During this period, the patient returned repeatedly to have the crown tightened because it continued to loosen. This year, it was decided to replace the crown using a new original ZIMVIE abutment. However, when the impression was taken, it was noted that the prosthesis would not fit into the implant hex. Upon further evaluation, it was observed that the implant was slightly fractured at the collar. After the healing period, a new implant with an original abutment will be placed. Tooth site 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096833 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 24 was removed due to Peri-implantitis. Discovered during second stage. Patient suffered inflammation. Bone graft was performed ans patient will return to place a new implant.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50096367 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported inflammation, supuration, edema and pain 10 days after surgery, which does not completely clear up with antibiotics and antiseptics. Doctor also indicated possible bone necrosis at both implants. There is a delay in procedure, waiting for the bone to heal. Patient has been rescheduled for new implants placement. Tooth site 32 and 36. Implants were removed.
Patient problems: Necrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50084487 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25303704 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25278950 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS. IMPLANT WITH PROTHESIS HAD MOBILITY, AND IMPLANT WAS REMOVED. TREATMENT WAS PERFORMED, AND THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24978628 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 44 & 46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24963598 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. IMPLANT WAS PLACED WITHOUT ANY APPARENT ISSUES BUT ONCE IT WAS LOADED WITH CROWN, IMPLANT CAUSED INFLAMMATORY DISCOMFORT WHICH PREVENTED ITS NORMAL FUNCTION. PATIENT REFERRED PAIN. NEW IMPLANTATION IS PLANNED IN THE FUTURE.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 24951505 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24831277 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #9 AND #11 WERE REMOVED AS THE IMPLANTS WERE NOT IN A POSITION FOR PROPOSED IMPLANT SUPPORTED FULL DENTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779727 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24680294 ↗MalfunctionMar 17, 2026Separation Failure
IT WAS REPORTED THAT THE MOUNT COULDN'T BE REMOVED FROM THE IMPLANT AT TOOTH SITE #25. DOCTOR HAD TO PROCEED WITH ANOTHER IMPLANT. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615163 ↗InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT TWO IMPLANTS AT TOOTH SITE # 15 AND 16 WERE REMOVED DUE TO A FRACTURE AT THE IMPLANTS COLLAR. THEREFORE THE CROWNS WERE LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516604 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24485070 ↗InjuryFeb 20, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT THE IMPLANT TOOTH LOCATION 14 WAS REMOVED DUE TO ALLERGIC REACTION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24399971 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN WITH SWELLING AND PAIN AROUND THE IMPLANT AT TOOTH SITE #12. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24393256 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 15 WAS REMOVED DUE TO A BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24371941 ↗InjuryFeb 16, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation
MAUDE report 24342268 ↗InjuryFeb 16, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342174 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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