NA SD800.435Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587065076), received between Sep 4, 2018 and Apr 22, 2025 — 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.

• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO INFECTION. IMPLANT 1: IN 2018, AFTER THE FIRST INTERVENTION, THE PATIENT SUFFERED A LIVER INFECTION THAT EVENTUALLY MIGRATED TO THE BRAIN AND THEREFORE HAD TO REMOVE THE IMPLANT FOR SAFETY. IMPLANT 2: IN 2023, AFTER THE SECOND OPERATION, THE PATIENT HAD ANOTHER INFECTION IN THE AREA OF THE IMPLANT WHICH ADVISED THE REMOVAL OF THE IMPLANT AGAIN. CURRENTLY, THE PATIENT SUFFERS FROM CRANIECTOMIZED SYNDROME, THAT IS TO SAY, THE BRAIN HAS NO PROTECTIVE BONE AND IS VERY SENSITIVE TO ITS OWN ATMOSPHERIC PRESSURE WHICH PREVENTS IT FROM LIVING A NORMAL LIFE. THE PATIENT CAN ONLY LIE DOWN WITHOUT SUFFERING FROM DIZZINESS, SO IT IS INDICATED A NEW PLASTIA THAT ALLOWS HIM TO RETURN TO NORMAL LIFE.

  Patient problems: Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21884984 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 18230482 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A PATIENT SPECIFIC IMPLANT (PSI) HAD DEVELOPED AN INFECTION AND WOULD REQUIRE ANOTHER PSI BONE FLAP. THE PATIENT EXPERIENCED AN ADVERSE EVENT. THIS REPORT IS FOR ONE (1) PSI SD800.435 PEEK IMPLANT. . THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18163089 ↗
• InjuryAug 24, 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, THE PSI IN QUESTION WAS REMOVED DUE TO AN INFECTION IN THE PATIENT¿S OPERATED AREA. THE PATIENT OUTCOME IS THAT THE CRANIOPLASTY MUST BE PERFORMED AGAIN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A PSI SD800.435 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15286929 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THIS REPORT WILL ADDRESS THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS. THE REMAINING DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) PSI PEEK IMPLANT. THIS IS REPORT 1 OF 10 (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7842039 ↗