NA SD800.527Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587065861), received between Jan 19, 2021 and Jul 18, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CUSTOM PEEK IMPLANT THAT WAS IMPLANTED BY SURGEON. THE PATIENT HAS RECENTLY COME BACK WITH AN INFECTION. SURGEON BELIEVES THE PATIENT HAD THE INFECTION FOR A NUMBER OF REASONS BUT DOES NOT BLAME THE INFECTION SOLELY ON THE IMPLANT. THE PATIENT DID NOT UNDERGO REMOVAL OF THE PRODUCTS. THE SURGEON PERFORMED A CRANIAL WASHOUT WHERE HE BURRED THE EXTERIOR SURFACE OF THE IMPLANT AND APPLIED A LARGE AMOUNT OF BETA DINE AND SALINE TO THE INFECTED AREA. THIS REPORT INVOLVES ONE (1) PSI SD800.527 PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19770156 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT DEVELOPED AN INFECTION, AND A NEW PATIENT SPECIFIC IMPLANT (PSI) HAS BEEN REQUESTED. THE PATIENT HAD IMPLANTS ON (B)(6) 2021. THE IMPLANT WAS REMOVED (B)(6) 2021, DUE TO INFECTION. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS FINE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) PSI SD800.527 PEEK IMPLANT. THIS REPORT IS 1 OF 15 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12619138 ↗
• MalfunctionJan 19, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT AN IMPLANT WAS TOO LARGE AND HAD TO BE MODIFIED INTRAOPERATIVELY. THE SURGEON USED A DRILL TO BURR A LITTLE BIT OFF THE EDGE OF THE IMPLANT. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE IMPLANT WAS SUCCESSFULLY IMPLANTED INTO PATIENT WITH NO ISSUE TO OUTCOME. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES 1 PSI SD800.527 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193550 ↗