NA SD800.539Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587065984), received between May 5, 2022 and Mar 5, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Nonstandard Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PEEK PSI DELIVERED DID NOT MEET SURGEON'S EXPECTATIONS IN TERMS OF SHAPE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523645 ↗
• InjuryMay 5, 2022Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE ISSUES WITH THE FIT OF THIS PSI. THE SURGERY WAS NOT ABLE TO BE COMPLETED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE PSI SD800.539 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14286118 ↗