NA SD420.433Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587069890), received between Jun 29, 2017 and Jun 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Distortion” (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 16, 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.

• InjuryJun 29, 2017Material Distortion; Material Distortion

  IT WAS REPORTED THAT A PATIENT SPECIFIC IMPLANT (PSI), A SYNTHES TITANIUM CRANIAL IMPLANT, DID NOT FIT PROPERLY DURING AN INITIAL CRANIOPLASTY PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO MODIFY THE PLATE; HOWEVER, WAS FORCED TO USE TITANIUM MESH INSTEAD. THERE WAS A 45 MINUTE DELAY IN SURGERY WHILE THE SURGEON ATTEMPTED TO MODIFY THE IMPLANT. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE: TITANIUM CRANIAL IMPLANT, WITH ONE PART DATA. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Code Available

  MAUDE report 6677371 ↗