TSV® BELLATEK® ENCODE® TEEHA365Recalls & reported problems
ZimVie US Corp LLC · TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 6.5MM(P) 5MM(H) · Class 2 · Implant
All models of TSV BELLATEK ENCODE (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868045793), received between Apr 24, 2025 and Mar 13, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 HAD A FRACTURED SCREW THAT NEEDED TO BE REMOVED. THE IMPLANT WAS IN THE PATIENT'S MOUTH WITHOUT ANY ISSUES. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REMOVE THE FRACTURED SCREW AND REPLACE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593658 ↗MalfunctionDec 12, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794488 ↗InjuryApr 24, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE INTERNAL SCREW ON HEALING ABUTMENT STRIPPED. EXTENSIVE TROUBLE RETRIEVING HEALING COLLAR WHICH INCLUDED REP ON SITE; SUSPECT THAT THIS COMPROMISED INTEGRATION. TOOTH #30. HAD TO DRILL AWAY AT HEALING ABUTMENT TO RETRIEVE; WOULD NOT HAVE BEEN ABLE TO RESTORE THIS IMPLANT. TOOK FOREVER; HAD TO RESCHEDULE PATIENT TO SEDATE HER TO GET ABUTMENT OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903986 ↗
Other Abutment, Implant, Dental, Endosseous devices
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- 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
- 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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