Skip to content

NA SD800.501Recalls & reported problems

Synthes GmbH · PSI SD800.501 PEEK IMPLANT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587065618), received between Dec 7, 2022 and Dec 7, 2022 — 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

Device problems

  • Defective Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 7, 2022Defective Device; Defective Device

    IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SURGEON NOTICED THAT AN IMPLANT AND VERIFICATION MODEL DID NOT HAVE THE SAME THICKNESS. IT WAS UNKNOWN WHETHER THERE WAS ANY PATIENT INVOLVEMENT. THERE WERE NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PSI SD800.501 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15936776 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

All PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page