Tapered Screw-Vent® Implant System 30AT335Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered Screw-Vent Implant System (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024013575), received between Oct 20, 2022 and Mar 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SCREW LOOSENED AND WAS RETIGHTENED TO 30 NCM EACH TIME. IT WAS REPORTED THAT THE SCREW KEPT LOOSENING ON 2 MULTI UNIT ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18880717 ↗InjuryOct 20, 2022Fracture; Fracture
IT WAS REPORTED THAT DR. INDICATED FRACTURE. 4 IMPLANTS WERE IMPLANTED ON THE UPPER JAW ON (B)(6) 2021. THE IMPLANT TORQUE WAS 35N. THE PRIMARY STABILITY WAS GOOD. THE IMMEDIATE LOADING WAS PERFORMED. 1 YEAR AFTER TEMPORARY RESTORATION, 1 30°TAPERED ABUTMENT WAS LOOSE. THE FRACTURE OF THE CONNECTION PART BETWEEN ABUTMENT AND IMPLANT WAS FOUND. THE IMPLANT WAS REMOVED ON THE SAME DAY. IMPLANT SIZE: TSVTB13/ BATCH NUMBER 63791285.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642162 ↗
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- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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.
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