NA SD800.445Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587065168), received between Jun 19, 2017 and Sep 27, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) PATIENT SPECIFIC IMPLANT -POLYETHERETHERKETONE (PSI PEEK) DID NOT FIT DURING A CRANIOPLASTY DUE TO TRAUMA. THE SURGERY WAS COMPLETED BY TRIMMING THE PSI IMPLANT TO FIT. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY#UNKNOWN). UNKNOWN SCREW (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY#UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9130326 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SPECIFIC IMPLANT (PSI) PEEK IMPLANT, AS WELL AS THE SUPPORTING UNKNOWN PLATE AND SCREWS, WERE EXPLANTED DUE TO INFECTION. DATE OF IMPLANT AND DATE OF EXPLANT ARE NOT KNOWN. IT IS UNKNOWN IF THERE WAS ANY DELAY IN SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO X-RAYS WERE TAKEN. THIS REPORT IS FOR ONE (1) PSI PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 6649769 ↗