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NA SD800.510Recalls & reported problems

Synthes GmbH · PSI SD800.510 PEEK IMPLANT · Class 2 · Implant

Data updated Oct 13, 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 10887587065700), received between Jan 30, 2023 and Jan 30, 2023 — 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. How this data works · Data updated Oct 13, 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.

  • MalfunctionJan 30, 2023Defective Device; Defective Device

    IT WAS REPORTED THAT THE SALES CONSULTANT AND SURGEON WERE EXPECTING A DIFFERENT IMPLANT DESIGN. SURGERY HAS NOT TAKEN PLACE YET, AND THERE WERE NO PATIENT OR SURGEON INVOLVEMENT, THESE WERE FOUND DURING TESTING. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PSI SD800.510 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16266224 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

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Sources and updates

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