C-QUR MOSAIC 31106Recalls & reported problems
Atrium Medical Corporation · C-QUR Mosaic, 5.12in (13 cm) Round · Class 2 · Implant
All models of C-QUR MOSAIC (8)
Data updated Oct 18, 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 00650862311068), received between Apr 13, 2016 and Feb 13, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Flaked” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Flaked1
- Hole In Material1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2019Flaked
HOSPITAL REPORTED THAT THEY HAVE A PIECE OF C-QUR MESH THAT IS FLAKING ON THE SIDE WITH THE OMEGA 3 FATTY ACID. THE SURGEON WAS PERFORMING A VENTRAL HERNIA REPAIR AND WAS GOING TO USE THE MOSAIC MESH. HE REMOVED THE MESH FOR USE AND NOTICED THAT THE MESH WAS FLAKING. HE THEN GAVE THE PRODUCT BACK TO THE IMPLANT COORDINATOR AND USED ANOTHER PIECE. NO IMPACT TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8338073 ↗MalfunctionMar 7, 2017Hole In Material
WHEN SURGEON TRIED TO PASS A SUTURE THROUGH THE MIDDLE OF THE PRODUCT, THE PRODUCT HAD A HOLE TORN IN IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6383325 ↗InjuryApr 13, 2016Insufficient Device Problem Information
RECEIVED A REPORT THAT PATIENT NEEDED MESH REMOVED DUE TO INFECTION. DOCTOR REPORTED THAT THE PATIENT HAD INFECTION AT TWO PORT ENTRIES AND BEHIND THE MUSCLE IN FRONT OF MESH.
Patient problems: Unspecified Infection
MAUDE report 5574515 ↗
Other Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction devices
- C-QUR MOSAIC 31133Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction4 reports
- C-QUR MOSAIC 31107Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction3 reports
- C-QUR MOSAIC 31143Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction1 report
- C-QUR MOSAIC 31138Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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