BELLATEK® TSVLDAZR3Recalls & reported problems
ZimVie US Corp LLC · BELLATEK® ZIRCONIA ABUTMENT TSV 3.5MM · Class 2 · Implant
All models of BELLATEK (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868038054), received between May 23, 2024 and Mar 3, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Fracture
IT WAS REPORTED THAT THE HEX PORTION OF THE ABUTMENT BROKE OFF IN THE PATIENT'S MOUTH. THE LAB IS UNSURE IF THEY WILL REMAKE IN TI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496940 ↗MalfunctionOct 15, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302034 ↗MalfunctionOct 11, 2024Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED. NO FURTHER INFORMATION WAS PROVIDED. TOOTH SITE # 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434060 ↗MalfunctionAug 23, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20048064 ↗MalfunctionMay 23, 2024Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380523 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page