BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBON XENOGRAFT GRANULES .5ML,500-1000

    MDR report key: 6029856 · Received October 14, 2016

    Report

    Report Number
    3006946279-2016-00376
    Event Type
    Injury
    Date Received
    October 14, 2016
    Report Date
    September 16, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LYC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    FR 2015-03
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS REVEALS NO RECORDED ANOMALY OR DEVIATION. EVENT DATE - NI, EXPLANT DATE - NI, THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, THIS REPORT IS BEING FILED AND ZIMMER BIOMET IN THE U.S. MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K110449. CORRECTIVE ACTION WAS INITIATED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORAL BONE GRAFTING MATERIAL FAILED TO OSSEOINTEGRATE AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680616 ENDOBON XENOGRAFT GRANULES .5ML,500-1000 BONE GRAFTING MATERIAL, SYNTHETIC LYC BIOMET FRANCE S.A.R.L. N/A U0132316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention