BellaTek® Encode® TEHA4505Recalls & reported problems
ZimVie US Corp LLC · TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H) · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868040958), received between Jan 22, 2021 and Jun 4, 2025 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Separation Failure1
- Separation Problem1
Patient problems
- Inflammation1
- 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.
InjuryJun 4, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT ENCODE CAN'T BE REMOVED. IT LOOKS LIKE HAVING DAMAGE IN THE HOLE OF THE SCREW DRIVER. WE TRIED SPITING IT OUT BUT WE CAN'T, SO WE REMOVED THE IMPLANT. WE TRIED USING ICE BUT IT DIDN'T WORK. TOOTH #31.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145558 ↗MalfunctionMar 8, 2024Fracture; Fracture
IT WAS REPORTED THAT IMPLANT IN TOOTH SITE #14 HAD A MOBILE CROWN AND UPON REMOVAL, THE ABUTMENT SCREW WAS FRACTURED AND THE IMPLANT WAS FRACTURED AS WELL. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation
MAUDE report 18870618 ↗InjuryJan 22, 2021Separation Failure; Separation Failure
DOCTOR REPORTS THAT THE TEHA4505 ABUTMENT WAS LOCKED INTO THE IMPLANT, NOTHING COULD GET IT OFF. THE IMPLANT ITSELF ENDED UP LOSING INTEGRATION WHILE TRYING TO GET THE ABUTMENT OFF. EITHER THE IMPLANT OR THE ABUTMENT WAS STRIPPED. TOOTH SITE # 30. THE IMPLANT IS REPORTED AS A CONCOMITANT DEVICE.
Patient problems: No Information
MAUDE report 11216527 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.