Tapered Screw-Vent TSV4B10Recalls & 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 is placed in the jawbone. Of its 564 reports, 517 are injuries and 47 describe malfunctions. Patients mention infection in 322 reports, bone loss in 229 and pain in 125. Recent reports describe implants removed due to infection around the implant. There were no deaths. One recall, started in November 2017, covered two lots with different thread sizes that were mixed during manufacturing and may be mislabeled, and it is closed.
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
- 562
- Deaths reported
- 0
- Injuries reported
- 514
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 00889024019225), received between Jun 26, 2019 and Sep 29, 2026 — classified as 514 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Fracture” (76 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Nov 29, 2017Class IITerminated
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Z-1190-2018 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem433
- Fracture76
- Separation Failure22
- Component Missing10
- Tear, Rip or Hole in Device Packaging9
- Mechanical Problem6
- Failure to Osseointegrate4
- Loss of Osseointegration3
Patient problems
- Unspecified Infection317
- Osteolysis224
- No Clinical Signs, Symptoms or Conditions129
- Pain125
- Inflammation94
- No Information35
- Abscess28
- No Code Available26
Recent adverse event reports
The 25 most recent of 562 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 45 failed to integrate due to osteonecrosis and was removed. Pain was reported as a consequence.
Patient problems: Necrosis; Pain
MAUDE report 50929358 ↗InjurySep 29, 2026Fracture
It was reported the patient had a 4.1×10 mm implant placement. The patient recently returned for a follow-up due to discomfort; images revealed a crack in the implant, and it was subsequently removed.
Patient problems: Discomfort
MAUDE report 50928440 ↗MalfunctionSep 28, 2026Separation Failure
It was reported that the implant did not detach from the implant mount. The implant was removed. Tooth site 46. Procedure completed using another implant of the same size.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912783 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
No further event information is available at the time of this report.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50769590 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50647119 ↗InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50393421 ↗InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis. Patient referred pain. Tooth site 12.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50393406 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #3 was removed due to peri-implantitis, with inflammation.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50034940 ↗InjuryJun 12, 2026Fracture
IT WAS REPORTED THE IMPLANT AT TOOTH SITE #36 FRACTURED AT THE BODY CLOSE TO THE APICAL PART. IMPLANT WAS COMPLETELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25483074 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS BONE LOSS GREATER THAN 2/3 AROUND THE LENGTH OF THE IMPLANT AT TOOTH SITE #19 DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25414274 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25284919 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND #22 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25176029 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITES #12 AND #22 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25175809 ↗InjuryMay 14, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS REMOVED. FRACTURED CROWN AND IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174868 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PAIN AND ABSCESS AROUND THE IMPLANT AT TOOTH SITE #21. THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25101326 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 46 WAS REMOVED DUE TO A PERI-IMPLANTITIS. FORM INDICATED: THE PATIENT DID NOT RETURN TO THE CLINIC FROM (B)(6) 2021 UNTIL (B)(6) 2026. DURING THIS PERIOD, BONE LOSS OCCURRED. REGENERATION WAS ATTEMPTED, BUT THE BONE DID NOT IMPROVE. THE DOCTOR DECIDED TO REMOVE THE IMPLANT AND PLACED A NEW ONE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25066060 ↗InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN INFECTION AT TOOTH SITE #16. IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 24919735 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24832974 ↗InjuryMar 25, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS FRACTURED AND HAD FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690946 ↗MalfunctionMar 17, 2026Separation Failure
DOCTOR REPORTED THAT DURING IMPLANT PLACEMENT OF IMPLANT 4.1 X10, THE MOUNT DID NOT DETACH FROM THE IMPLANT AT TOOTH SITE # 13. THE IMPLANT WAS REMOVED AND WAS REPLACED WITH ANOTHER ONE OF THE SAME SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615120 ↗InjuryMar 12, 2026Fracture
IT WAS REPORTED THAT THE PATIENT NOTICED MOBILITY AT THE IMPLANT IN TOOTH SITE 46, AND AFTER INSPECTION IT WAS REMOVED DUE TO A FRACTURE AT THE NECK. PATIENT EXPERIENCED INFLAMMATION.
Patient problems: Inflammation
MAUDE report 24578007 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS RECEIVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24562413 ↗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 24516550 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24501227 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24326707 ↗
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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 · each recall links to the FDA recall notice
- 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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