NA SD800.541Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587066004), received between Jun 29, 2017 and Dec 12, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS BEING REMOVED DUE TO INFECTION. THIS REPORT IS FOR ONE (1) PSI SD800.541 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15959026 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN IMPLANT WAS REMOVED DUE TO COMPLICATIONS/SWELLING. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A PSI SD800.541 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 15698983 ↗
• InjuryApr 27, 2020Adverse 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 SOFT TISSUE INFECTION ON SCALP, SO THE SURGEON HAD TO REMOVE THE PEEK IMPLANT TO TREAT THE INFECTION. AT A LATER DATE WHEN INFECTION RESIDES, A NEW PEEK IMPLANT WILL BE MADE AND IMPLANTED. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. PATIENT INVOLVEMENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PSI SD800.541 PEEK IMPLANT. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10003265 ↗
• MalfunctionOct 17, 2019Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available

  THE SURGEON COMPLETED THE SURGERY AND PLATE HAD SLIGHT GAP NEXT TO BONE. THERE WAS NO SURGICAL DELAY. THERE WILL BE NO REVISION SURGERY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200779 ↗
• InjuryJun 29, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A PATIENT SPECIFIC IMPLANT (PSI) COULD NOT BE USED IN SURGERY DUE TO THE IMPLANT NOT FITTING PROPERLY. IT WAS FURTHER EXPLAINED THAT THE PSI WAS NOTED TO FIT ON ONE SIDE BUT NOT THE OTHER. THE SURGEON DECIDED TO CUT THE IMPLANT IN HALF AND GO AHEAD AND IMPLANT IT IN THE PATIENT AS PLANNED. THERE WAS AN UNKNOWN SURGICAL DELAY DUE TO THE CHANGE IN THE SURGICAL PLAN AND THE ADJUSTMENTS REQUIRED TO MAKE THE PSI FIT. IT IS UNKNOWN WHAT DEVICES WERE USED TO CUT THE IMPLANT IN HALF, WHAT DEVICES WERE USED TO ASSIST WITH THE FITTING. PLATES MAY HAVE BEEN USED TO SPAN THE MIDDLE OF THE PSI BUT THIS HAS NOT BEEN CONFIRMED. TO THE REPORTER'S KNOWLEDGE, THERE WAS NO HARM TO THE PATIENT. THE SURGEON IS CONSIDERING A REVISION BUT, TO DATE, A REVISION SURGERY HAS NOT BEEN SCHEDULED. THIS REPORT IS FOR ONE (1) PSI PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Code Available

  MAUDE report 6679631 ↗