NA SD800.428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587065014), received between Jun 1, 2017 and Sep 27, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION AFTER UNDERGOING CRANIOPLASTY. THE PATIENT HAS HAD THE IMPLANT FOR ABOUT A MONTH. IMPLANT WAS REMOVED AND NEW IMPLANT IS BEING CREATED.

  Patient problems: Unspecified Infection

  MAUDE report 20317655 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PEEK IMPLANT WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. PSI SD800.428 PEEK IMPLANT. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16466423 ↗
• InjuryJun 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SPECIFIC IMPLANT (PSI) PEEK IMPLANT DID NOT MATCH A PATIENT'S CRANIAL DEFECT DURING A CRANIOPLASTY SURGERY ON (B)(6) 2017. DUE TO THE FACT THAT THE IMPLANT DID NOT MATCH THE PATIENT'S SKULL DEFECT, THE SURGEON HAD TO MOLD A NEW IMPLANT USING SURGICAL CEMENT. THERE WAS A REPORTED SURGICAL DELAY OF TWENTY (20) MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) PSI PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 6606305 ↗