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GUIDOR C11-078Recalls & reported problems

Sunstar Americas, Inc. · easy-graft CLASSIC Bone grafting material, synthetic · 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 07640164360096), received between Aug 11, 2016 and Aug 11, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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

  • Component Missing1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 11, 2016Component Missing

    DOCTOR HAD PLACED THE PRODUCT IN A PREMOLAR THAT WAS MISSING A BONY WALL. AFTER TWO WEEKS THE PATIENT CONTACTED THE DOCTOR AND INFORMED HIM THAT THE SITE IS SWOLLEN & INFECTED. PATIENT WAS IN A LOT OF PAIN. AS PER DOCTOR, A HANDLING OF THE PRODUCT WAS FINE AND THE SITE WAS NOT OVERFILLED BY THE PRODUCT. THE PATIENT HAS NO KNOWN ALLERGIES. DOCTOR REMOVED THE PRODUCT FROM THE SITE. COMPLAINT # (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 5869020 ↗

Other Bone Grafting Material, Synthetic devices

All Bone Grafting Material, Synthetic devices →

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