NA SD800.441Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587065120), received between Mar 27, 2019 and Dec 5, 2023 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PSI (PATIENT SPECIFIC IMPLANT) WAS REMOVED DUE TO AN INFECTION IN THE PATIENT¿S OPERATED AREA. THIS PATIENT HAD A HISTORY OF PREVIOUS INFECTION. THIS REPORT INVOLVES ONE PSI SD800.441 PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18266245 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED THE PSI (PATIENT SPECIFIC IMPLANT) POSTOPERATIVELY DUE TO AN INFECTION IN THE PATIENT¿S OPERATED AREA. THIS PATIENT HAD A PREVIOUS HISTORY OF INFECTION. THIS REPORT INVOLVES ONE PSI SD800.441 PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18236339 ↗
• InjuryAug 11, 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, A REVISION PROCEDURE WAS PERFORMED TO REMOVE A PSI ORIGINALLY IMPLANTED ON (B)(6) 2021. THE PROCEDURE WAS PERFORMED DUE TO AN INFECTION IN THE PATIENT¿S OPERATED AREA. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PSI SD800.441 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15209190 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT WE RECEIVED INFORMATION FROM THE FIELD THAT THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION. THIS COMPLAINT INVOLVES (1) DEVICE PSI SD800.441 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14146990 ↗
• InjuryMar 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  4/30/2019. UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY OF TWO (2) PSI, AN UNKNOWN NUMBER OF UNKNOWN PLATES, AND AN UNKNOWN NUMBER OF UNKNOWN SCREWS DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 8455769 ↗