RapidSorb 851.801.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587064239), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionJan 19, 2018Break; Break

  IT WAS REPORTED THAT THERE WERE REPORTS OF BREAKAGE OF THE IMPLANT DURING IMPLANTATION FROM A SURVEY BY THE CLINICAL TEAM FILLED OUT BY ONE SURGEON WHO HAD USED THE RAPIDSORB CRANIAL CLAMP. THE ACTUAL NUMBER OF CASES THAT THESE MALFUNCTIONS HAVE OCCURRED IN IS UNKNOWN. THIS IS BECAUSE BASED ON THE SURVEY DESIGN, THE PERCENTAGES OF MALFUNCTIONS AND ADVERSE EVENTS ARE AS PER THE SURGEON'S PERCEPTION AND MAY NOT BE AN ACTUAL CALCULATED NUMBER. THE SURGEON HAS BEEN INVOLVED IN AT LEAST TWENTY-ONE (21) SURGERIES OF CHILDREN WITH THE RAPIDSORB CRANIAL CLAMP. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR AN UNKNOWN NUMBER OF CLAMPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7205459 ↗