NA SD800.426Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587064505), received between Apr 16, 2018 and Sep 16, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjurySep 16, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A FAILURE IN THE DELIVERY REVIEW FILTERS FOR THIS IMPLANT ON THE PART OF THE HOSPITAL AND THE DELIVERER. THIS INCIDENT WAS DETECTED WHEN THE PATIENT WAS UNDERGOING SURGERY. THE SURGERY HAD TO BE RESCHEDULED FOR TWO DAYS LATER. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THIS REPORT INVOLVES ONE PSI SD800.426 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15436873 ↗
• InjuryJun 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A CRANIOTOMY ON (B)(6) 2018, A PATIENT SPECIFIC (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT DID NOT FIT THE DEFECT PROPERLY ALONG THE POSTERIOR EDGE. THE IMPLANT WAS OFF BY ABOUT 1MM. THE SURGEON BURRED DOWN THE BONE TO MAKE THE IMPLANT FIT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 15 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A PSI (B)(4) PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 7588842 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, THE IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. IT IS UNKNOWN IF IMPLANTS WERE SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THIS REPORT IS FOR A PSI SD800.426 PEEK IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7537195 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF A PEEK PSI IMPLANT (CRANIOTOMY) ON AN UNKNOWN DATE IN (B)(6) DUE TO AN INFECTION. THE PATIENT UNDERWENT AN INITIAL CRANIOTOMY PROCEDURE IN (B)(6) 2017 TO BE IMPLANTED WITH THE SYNTHES PEEK PSI IMPLANT AS A BONE FLAP ALONG WITH AN UNKNOWN QUANTITY OF UNKNOWN SCREWS (MANUFACTURED BY A COMPETITOR) TO FIXATE THE IMPLANT. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION IN THE VICINITY OF THE IMPLANTS AND HENCE UNDERWENT THE REMOVAL OF ALL IMPLANTED DEVICES. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. THE STATUS OF THE PATIENT, SUFFERING FROM CANCER, WAS UNKNOWN AT THE END OF THE REMOVAL PROCEDURE. THE FACILITY PLANS TO RE STERILIZE THE PEEK PSI IMPLANT AND REUSE IN THIS PATIENT. THIS REPORT IS FOR ONE (1) PSI SD800.426 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7434475 ↗