BELLATEK® TSVLDAT4Recalls & reported problems
ZimVie US Corp LLC · BELLATEK® ABUTMENT TSV 4.5MM · Class 2 · Implant
All models of BELLATEK (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868038092), received between Oct 30, 2020 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (2 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
- Unintended Movement2
- Fracture1
Patient problems
- Difficulty Chewing1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
It was reported that patient presented with implant crown in hand, reports it came out two days ago. Exam revealed fractured hex off of Bellatek Custom abutment and fractured prosthetic screw. Remaining portion of screw in pt¿s #30 site along with fractured portion of custom abutment hex. Remaining portion of fractured device removed under local anesthesia and tissue punch to remove gingival overgrowth. Placed TEEHA465 encode for healing. Patientt unable to fully masticate on a right side. Abutment placed on (b)(6) 2024 and removed on (b)(6) 2026.
Patient problems: Difficulty Chewing
MAUDE report 50948112 ↗MalfunctionMay 15, 2024Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19320686 ↗MalfunctionOct 30, 2020Unintended Movement; Unintended Movement
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: No Information
MAUDE report 10762945 ↗
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- 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
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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