BELLATEK® CSHY05Recalls & reported problems
ZimVie US Corp LLC · BELLATEK® HYBRID BAR 5 IMPLANTS · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868001683), received between Oct 26, 2022 and Jun 16, 2025 — classified as 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
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN THE PATIENT¿S MOUTH ON THE CYLINDER IN THE TOOTH #29/30 AREA. THE PATIENT WILL BE WEARING THE BAR AS A TEMPORARY UNTIL THE NEW BAR IS COMPLETED AND INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214332 ↗MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN HALF IN THE PATIENT¿S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634907 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR FRACTURED IN PATIENT¿S MOUTH BETWEEN TOOTH NUMBERS 20 AND 21. BAR WILL BE REMADE BEETWEN TOOTH-20,22,24,25,28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397862 ↗MalfunctionJan 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16241094 ↗MalfunctionOct 26, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DENTAL BAR FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15675324 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.