TSV® BELLATEK® ENCODE® TEEHA355Recalls & reported problems
ZimVie US Corp LLC · TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H) · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868045762), received between Mar 1, 2024 and May 11, 2026 — classified as 4 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device4
- Separation Failure3
- Positioning Failure2
- Use of Device Problem2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS IMPOSSIBLE TO PLACE. ANOTHER HEALING ABUTMENT USED WITHOUT PROBLEMS. IMPLANT HAD BEEN PLACED (B)(6) 2025 AT TOOTH SITE 46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134675 ↗MalfunctionApr 20, 2026Separation Problem
IT WAS REPORTED THAT WHEN WE PUT THE HEALING ABUTMENT IN THE DR. DIDN'T LIKE THE POSITION OF THE IMPLANT SO WE DECIDED TO TAKE THE ABUTMENT OUT AND THE IMPLANT CAME WITH IT. SO THEY GOT STUCK TOGETHER. WE HAD TO PLACE ANOTHER IMPLANT DUE TO THE HEALING ABUTMENT AND IMPLANT STICKING TOGETHER. HAD TO TAKE THE IMPLANT AND ABUTMENT OUT AND PUT A NEW IMPLANT AND ABUTMENT IN. SO IT ADDED MORE TIME ON TO THE APPOINTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925051 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551893 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551648 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551520 ↗MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713722 ↗MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem
THE DOCTOR REPORTED THAT THE TWO ABUTMENTS DO NOT SEAT PROPERLY. NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713693 ↗InjuryNov 4, 2025Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466028 ↗MalfunctionJun 23, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS PLACED ON THE IMPLANT AT TOOTH SITE #14 BUT COULD NOT BE SEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309449 ↗InjuryDec 5, 2024Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854303 ↗InjuryJun 10, 2024Separation Failure; Separation Failure
THE DOCTOR REPORTS THAT THE EMERGENCE HEALING ABUTMENT DOES NOT DETACH FROM THE IMPLANT, FINDING IT IMPOSSIBLE TO DO SO. IT WAS SCREWED IN AT 20 NEWTONS. THE AFFECTED DENTAL POSITION IS #36. THE PROCEDURE WAS COMPLETED USING ANOTHER ABUTMENT AND ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497969 ↗InjuryMar 1, 2024Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 6 REMOVED DUE TO STRIPPED HEALING ABUTMENT. DENTIST STRIPPED HEX OF HEALING ABUTMENT. COULD NOT REMOVE SCREW ON HEALING ABUTMENT AFTER RESTORATIVE DOCTOR STRIPPED THE INTERNAL HEX. I ATTEMPTED TO CUT OFF THE ABUTMENT BUT DUE TO RISK OF DAMAGE TO IMPLANT, OPTED TO REMOVE IMPLANT & REPLACE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18817940 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.