NA SD800.429Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587065021), received between Apr 30, 2021 and Apr 30, 2021 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) DIDN'T FIT. PATIENT WAS ON THE TABLE AND SURGERY WAS MOVING FORWARD AS PLANNED. IMPLANT WAS PEEL PACKED AWAITING FOR PLACEMENT AS DISSECTION WAS TAKING PLACE. ONCE THE DISSECTION WAS COMPLETED, THE SURGEON PROCEEDED TO BEGIN FITTING THE IMPLANT AND THAT'S WHEN IT WAS DISCOVERED THAT THE IMPLANT WAS AT A MINIMUM OF 1CM OFF FROM THE FRONTAL AREA OF THE WHICH THE IMPLANT WAS SUPPOSED TO COVER. THE IMPLANT WAS NOT LONG ENOUGH TO COVER THE DEFECT. A SECOND PSI PEEK IMPLANT WAS PLANNED FOR USE IN THE PROCEDURE AND HAD NO ISSUES. SURGERY WAS DELAYED FOR FORTY-FIVE (45) MINUTES BEFORE THE SURGEON DECIDED TO POSTPONE THE PROCEDURE FOR ISSUES NOT RELATED TO THE PSI FIT ISSUE; PROCEDURE WILL BE RESCHEDULED. THIS REPORT IS FOR A PSI SD800.429 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752138 ↗