NA SD800.419Recalls & reported problems
Synthes GmbH · PSI SD800.419 PEEK IMPLANT · Class 2 · Implant
- 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 10887587064499), received between Jul 14, 2025 and Jul 14, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Defective Device; Defective Device
IT WAS REPORTED THAT THE HCP/CUSTOMER HAD SOME FEEDBACK REGARDING THE PEEK IMPLANT AND HE MENTIONED THAT THE HEIGHT ON THE ORBITAL OF THE PEEK IMPLANT WAS NOT IDEAL AND DIDN¿T FIT AS PLANNED FOR CRANIAL RECONSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 22494633 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.