NA SD800.540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587065991), received between Mar 2, 2018 and Sep 26, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse 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 AN INFECTION AFTER UNDERGOING CRANIOPLASTY. THE PATIENT HAS HAD THE IMPLANT FOR ABOUT A MONTH. IMPLANT WAS REMOVED AND NEW IMPLANT IS BEING CREATED.

  Patient problems: Unspecified Infection

  MAUDE report 20313272 ↗
• InjuryAug 13, 2024Defective Device; Defective Device

  IT WAS REPORTED, THAT ON JULY 16, 2024. THE ITEM DID NOT FIT, DUE TO SOFT TISSUE INTERFERENCE. IMPLANT WAS ABOUT 1CM PROMINENT ON DEFECT. THERE WAS A SOFT TISSUE OVERLAY THAT DID NOT ALLOW FOR FIT. IT IS UNKNOWN, IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) PSI SD800.540 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978174 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT WAS REMOVED DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PSI SD800.540 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16223025 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER TO THE SALES REP THAT ON AN UNKNOWN DATE, THE IMPLANT DEVICE WILL BE REMOVED DUE TO SOFT TISSUE BREAKDOWN. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAIN INVOLVES ONE (1) DEVICE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14272610 ↗
• MalfunctionJul 17, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS NOT HAPPY WITH THE FIT OF THE PATIENT-SPECIFIC IMPLANT (PSI) PEEK IMPLANT IN THE FIELD. SURGICAL PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A PSI SD800.540 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798493 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PATIENT SPECIFIC IMPLANT, MATRIXNEURO PLATES AND MATRIXNEURO SCREWS ON (B)(6) 2018 FOR A CRANIOPLASTY. PATIENT DEVELOPED INFECTION AND THE IMPLANTS WERE REMOVED ON AN UNKNOWN DATE. PATIENT WILL BE IMPLANTED WITH ANOTHER PATIENT SPECIFIC IMPLANT. THE SURGERY DATE HAS NOT BEEN SCHEDULED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES (PATIENT SPECIFIC IMPLANT, MATRIXNEURO PLATES AND MATRIXNEURO SCREWS). THIS REPORT IS FOR 10 DEVICES. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7310180 ↗