NA SD800.439Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587064512), received between Aug 27, 2021 and Sep 23, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS AN ISSUE WITH A CUSTOM PEEK CRANIAL IMPLANT. THE IMPLANT DESIGN WAS SEVERELY OFF AND DID NOT IMPLANT INTO THE PATIENT CORRECTLY PER CUSTOM FIT. THE SURGEON HAD TO ALTER THE IMPLANT INTRA-OP AND USE A PIECE OF TITANIUM MESH TO COVER THE GAPS. THE DESIGN OF THIS IMPLANT WAS DONE FROM MERGING TWO CT SCANS TOGETHER. THE PATIENT WAS UNABLE TO HOLD STILL DURING THE SCANS DUE TO UNDERLYING HEALTH ISSUES. THE SURGERY WAS COMPLETED AND THE PATIENT WAS WOKEN UP POST SURGERY DOING WELL. THIS REPORT IS FOR ONE (1) PSI SD800.439 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473234 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION. THIS REPORT INVOLVES ONE PSI SD800.439 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15380501 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PSI IN QUESTION WAS REMOVED DUE TO AN INFECTION IN THE PATIENT¿S OPERATED AREA. THE PATIENT OUTCOME IS THAT THE CRANIOPLASTY MUST BE PERFORMED AGAIN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A PSI SD800.439 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15287024 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE PROCEDURE WAS A CRANIOPLASTY. THE IMPLANTATION OF THE CAD IMPLANT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. THE PATIENT WILL GET A NEW IMPLANT (MATRIXNEURO TITANIUM MESH) AFTER SUCCESSFUL ANTIBIOTIC THERAPY.

  Patient problems: Abscess

  MAUDE report 12379009 ↗