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ECLIPSE FLAT RIBBON PISTON 472-450Recalls & reported problems

Grace Medical, Inc. · ECLIPSE FLAT RIBBON PISTON 0.6MM DIA X 4.50MM L NITINOL FLUOROPLASTIC · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844505009362), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of 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

  • Malposition of Device1

Patient problems

  • No Information1

Recent adverse event reports

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

  • InjuryMar 1, 2019Malposition of Device

    IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DURING A REVISION SURGERY, AS THE LOOP OF THE STAPES PROSTHESIS WAS FOUND TO BE IN THE OPENED POSITION AND LYING IN THE MIDDLE EAR SPACE.

    Patient problems: No Information

    MAUDE report 8383243 ↗

Other PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.