BELLATEK® CSHY04Recalls & reported problems
ZimVie US Corp LLC · BELLATEK® HYBRID BAR 4 IMPLANTS · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868001676), received between Mar 31, 2020 and Jan 6, 2025 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FREE-END SADDLE OF THE BAR BROKE OFF AT SITE # 28-29 AREA. LAB WILL BE SENDING BACK AS WELL AS HAVING BAR REMADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079906 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FREE-END SADDLE OF THE BAR BROKE OFF AT SITE # 28-29 AREA. LAB PREVIOUSLY REPAIRED THE WEEK OF DECEMBER 2ND. BAR BROKE AGAIN. LAB WILL BE SENDING BACK AS WELL AS HAVING BAR REMADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079796 ↗MalfunctionDec 26, 2024Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN PATIENT'S MOUTH. WILL BE RETURNING THE BROKEN ONE AND REMAKING A NEW BAR. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021203 ↗MalfunctionFeb 23, 2024Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18768214 ↗MalfunctionFeb 2, 2023Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN PATIENT'S MOUTH AND WILL NEED TO BE REMADE. THE PATIENT WILL STILL WEAR THE BAR UNTIL THE NEW ONE IS MADE. THE FRACTURE OCCURRED AROUND TOOTH #27 ON THE SIDE OF THE LAST IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16287582 ↗InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED FROM SITE 14 DUE TO INFECTION. THE PATIENT WILL RETURN FOR NEW IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 9902904 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.