GRYPHON PERMACORD 223148Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705024636), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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.

• MalfunctionJul 26, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON¿ PEEK ANCHOR WITH PERMACORD¿ SIZE 2, 36" DEVICE HAD A TINY TEAR IN THE WRAPPER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS RECEIVED IN AN OPENED FOIL POUCH WITH A DAMAGE TO THE FOIL POUCH MARKED WITH A BLUE CIRCLE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396937 ↗