NA SD800.433Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587065069), received between Dec 17, 2018 and May 2, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT THE PRODUCED PSI IMPLANT DID NOT FIT THE PATIENT'S BONE DEFECT. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT AND UNKNOWN IF PATIENT HAD ANY ADVERSE CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. (B)(4) IS RELATED WITH (B)(4). THIS REPORT IS FOR ONE (1) PSI SD800.433 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854724 ↗
• MalfunctionMar 2, 2023Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE PRODUCED PSI IMPLANT DID NOT FIT THE PATIENT'S BONE DEFECT. SURGERY WAS DELAYED FOR 10 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) PSI SD800.433 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466202 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A PEEK IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 14084110 ↗
• MalfunctionNov 19, 2019Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE ON (B)(6) 2019, A PATIENT-SPECIFIC IMPLANT (PSI) PEEK IMPLANT DID NOT FIT. THE IMPLANT WAS TO REPLACE THE ENTIRE FRONTAL BONE OF THE PATIENT. WHEN THE SURGEON PLACED IT, HE NOTICED A SMALL DISCREPANCY IN THE FIT TO THE TOP OF THE NASAL BONE. THE IMPLANT WAS SHAPED AND THE SURGEON FELT THAT IT WAS SUFFICIENT TO CLOSE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR 1 PLATE, CRANIOPLAST, PREFORMED, NONALTERABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9343742 ↗
• 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 2 OF 2 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9130373 ↗
• 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 8455749 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO SUSPECTED INFECTION. TWO PEEK IMPLANTS WERE REPLACED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8170108 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO SUSPECTED INFECTION.TWO PEEK IMPLANTS WERE REPLACED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8170080 ↗