C-QUR MOSAIC 31107Recalls & reported problems
Atrium Medical Corporation · C-QUR Mosaic, 5.90in (15 cm) Round · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862311075), received between Dec 15, 2016 and May 25, 2023 — classified as 3 injuries.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Flaked1
- Output Problem1
Patient problems
- Adhesion(s)2
- Hernia1
- No Consequences Or Impact To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PLAINTIFF ALSO ALLEGEDLY EXPERIENCED SEPARATED MESH AND ADHESIONS.
Patient problems: Adhesion(s); Hernia
MAUDE report 17002847 ↗InjuryJul 5, 2022Output Problem
THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED SEVERE ABDOMINAL PAIN, DIGESTIVE PROBLEMS, SCAR TISSUE, INFECTION, MESH REMOVAL, WOUND VAC TREATMENT, ADHESIONS, DEBRIDEMENT OF THE SKIN AND ADDITIONAL SURGERIES. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.
Patient problems: Adhesion(s); Pain; Unspecified Infection
MAUDE report 14914544 ↗InjuryDec 15, 2016Flaked
HOSPITAL REPORTED THEY HAD TIGHTENED TRANSFACIAL SUTURES AND RAN THE ARM OF THE TACKER ACROSS THE MESH TO REACH THE OTHER SIDE, COATING FLAKED OFF WHERE MESH WAS PULLED TIGHT. ALSO FLAKED AT SITE OF TIED SUTURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6175291 ↗
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 31106Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction3 reports
- C-QUR MOSAIC 31138Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction1 report
- C-QUR MOSAIC 31143Atrium Medical Corporation · Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.