CRANIOS Reinforced 616.05.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587058689), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• MalfunctionMar 19, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THE CIRCULATING NURSE WAS TRYING TO MIX A 5CC CRANIOS REINFORCED ROTARY MIX, AND WHEN THE NURSE ATTACHED THE SOLUTION SYRINGE TO THE ONE WAY VALVE AND STARTED TO INJECT THE SOLUTION WOULD NOT GO INTO THE MIXING POUCH AND BEGAN LEAKING OUT THROUGH THE LUER LOCK SYRINGE AND THE ONE WAY VALVE. NO DELAY IN SURGERY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE CRANIOS REINFORCED ROTARY MIX 5CC-SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827560 ↗