XCM Biologic® Tissue Matrix 30010-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812337020312), received between Jul 7, 2016 and Jul 7, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2016Degraded; Torn Material; Degraded; Torn Material

  THE PATIENT WAS FEMALE WITH A SIGNIFICANT SURGICAL HISTORY CONSISTING OF COLECTOMY, STOMA, STOMA REVERSAL, FISTULA, AND HERNIA REPAIR. ON (B)(6) 2016, ANOTHER ABDOMINAL SURGERY WAS PERFORMED THAT INVOLVED SIGNIFICANT ADHESIOLYSIS, FISTULA DEBRIDEMENT AND CLOSURE, AND RESECTION OF PREVIOUSLY PLACED MESH. THE SURGICAL SITE WAS CONSIDERED TO BE CONTAMINATED. THE SURGEON WAS NOT ABLE TO RE-APPROXIMATE THE RECTUS MUSCLES. THEREFORE, XCM BIOLOGIC WAS IMPLANTED TO BRIDGE THE GAP IN THE ABDOMINAL WALL. APPROXIMATELY 2 WEEKS LATER, THE PATIENT PRESENTED WITH WOUND DEHISCENCE AND A SMALL BOWEL FISTULA. UPON REOPERATION, THE SURGEON REPORTED THAT THE MESH HAD DETACHED FROM THE RIGHT SIDE AND WAS BUNCHED UP ON THE LEFT SIDE OF THE ABDOMEN. THE MESH WAS DESCRIBED AS JELLY-LIKE IN APPEARANCE. THE SURGEON REMOVED THE XCM BIOLOGIC MESH AND IMPLANTED VICRYL MESH TO COVER THE DEFECT. THE PATIENT WAS STILL IN THE HOSPITAL ONE WEEK LATER, BUT WAS NO LONGER SEPTIC.

  Patient problems: Fistula; Sepsis; Wound Dehiscence

  MAUDE report 5775060 ↗