NA 329.317Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587039275), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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.

• MalfunctionMay 21, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT WAS DELIVERED TO STERILIZATION UNIT WITH A NOTE THAT IT DOES WORK. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE DISTAL PORTION OF THE PUSH ARM COMPONENT WAS SLIGHTLY BROKEN AND RUST WAS OBSERVED ON THE UPPER JAW COMPONENT. THIS REPORT IS FOR ONE (1) APPLICATION DEVICE FOR RESORBABLE CRANIAL CLAMP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867173 ↗